HemoSphere HEMCSM10Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00690103202762), received between Nov 15, 2021 and Sep 15, 2026 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (26 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that during use of the Clearsight module the user kept getting inaccurate readings.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774306 ↗
• MalfunctionJan 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE CLEARSIGHT MODULE IT WAS PROVIDING LOW SYSTOLIC AND MAP PRESSURE VALUES COMPARED TO THE ARTERIAL AND BRACHIAL MEASUREMENTS ON THE PATIENTS BEDSIDE GE MONITOR. THE VALUES RANGED ANYWHERE FROM 10 TO 30 POINTS DIFFERENT IN THE SYSTOLIC PRESSURE. FOR THE MAP THE DIFFERENCE COULD BE 10 UP TO 20 POINTS DIFFERENCE. THE PATIENT HAD A BRACHIAL OSCILLOMETRIC CUFF ON THE SAME SIDE AS THE ACUMEN CUFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206120 ↗
• MalfunctionJan 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE CLEARSIGHT MODULE IT WAS PROVIDING LOW SYSTOLIC AND MAP PRESSURE VALUES COMPARED TO THE ARTERIAL AND BRACHIAL MEASUREMENTS ON THE PATIENTS BEDSIDE GE MONITOR. THE VALUES RANGED ANYWHERE FROM 10 TO 70 POINTS DIFFERENT IN THE SYSTOLIC PRESSURE. FOR THE MAP THE DIFFERENCE COULD BE 10 UP TO 30 POINTS DIFFERENCE. THE PATIENT HAD A BRACHIAL OSCILLOMETRIC CUFF ON. IT WAS ON THE OPPOSITE ARM THEN IT WAS MOVED TO THE SAME SIDE AS THE ACUMEN CUFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206118 ↗
• MalfunctionNov 17, 2025High Readings; High Readings

  AS REPORTED, DURING USE OF THIS HEMOSPHERE CLEARSIGHT MODULE IN THREE DIFFERENT PROCEDURES (LARYNGECTOMY, GASTRECTOMY AND HEMICOLECTOMY), THE BLOOD PRESSURE VALUES DISPLAYED WERE 20 MMHG HIGHER THAN THOSE SHOWN ON THE ANESTHESIA MONITOR (MANUFACTURER COMPLAINT REFERENCES (B)(6) RESPECTIVELY). THE PRESSURE CONTROLLER, TRIFURCATED CABLE AND HEART REFERENCE SENSOR WERE TESTED WITHOUT SUCCESS. THERE WAS NO ERROR MESSAGE OR ALARM DISPLAYED. IT WAS DURING THE HEMICOLECTOMY CASE THAT THE ISSUE WAS RESOLVED REPLACING THE CLEARSIGHT MODULE, AFTER CONFIRMING THE ACCURACY OF THE ANESTHESIA MONITOR VALUES USING A BRACHIAL CUFF. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23567649 ↗
• MalfunctionNov 17, 2025High Readings; High Readings

  AS REPORTED, DURING USE OF THIS HEMOSPHERE CLEARSIGHT MODULE IN THREE DIFFERENT PROCEDURES (LARYNGECTOMY, GASTRECTOMY AND HEMICOLECTOMY), THE BLOOD PRESSURE VALUES DISPLAYED WERE 20 MMHG HIGHER THAN THOSE SHOWN ON THE ANESTHESIA MONITOR (MANUFACTURER COMPLAINT REFERENCES (B)(6) RESPECTIVELY). THE PRESSURE CONTROLLER, TRIFURCATED CABLE AND HEART REFERENCE SENSOR WERE TESTED WITHOUT SUCCESS. THERE WAS NO ERROR MESSAGE OR ALARM DISPLAYED. IT WAS DURING THE HEMICOLECTOMY CASE THAT THE ISSUE WAS RESOLVED REPLACING THE CLEARSIGHT MODULE, AFTER CONFIRMING THE ACCURACY OF THE ANESTHESIA MONITOR VALUES USING A BRACHIAL CUFF. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23567341 ↗
• MalfunctionNov 17, 2025High Readings; High Readings

  AS REPORTED, DURING USE OF THIS HEMOSPHERE CLEARSIGHT MODULE IN THREE DIFFERENT PROCEDURES (LARYNGECTOMY, GASTRECTOMY AND HEMICOLECTOMY), THE BLOOD PRESSURE VALUES DISPLAYED WERE 20 MMHG HIGHER THAN THOSE SHOWN ON THE ANESTHESIA MONITOR (MANUFACTURER COMPLAINT REFERENCES (B)(4) RESPECTIVELY). THE PRESSURE CONTROLLER, TRIFURCATED CABLE AND HEART REFERENCE SENSOR WERE TESTED WITHOUT SUCCESS. THERE WAS NO ERROR MESSAGE OR ALARM DISPLAYED. IT WAS DURING THE HEMICOLECTOMY CASE THAT THE ISSUE WAS RESOLVED REPLACING THE CLEARSIGHT MODULE, AFTER CONFIRMING THE ACCURACY OF THE ANESTHESIA MONITOR VALUES USING A BRACHIAL CUFF. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23567198 ↗
• MalfunctionJan 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED DURING USE THAT THERE WERE INACCURATE BLOOD PRESSURE VALUES WITH THE CLEARSIGHT MODULE. THE DISPLAYED NUMBERS WERE 20 TO 40 POINTS DIFFERENT FROM THE BLOOD PRESSURE CUFF READING. THE CLEARSIGHT READING WOULD STOP AND A FAULT MESSAGE OF "PUMP MALFUNCTION" WAS DISPLAYED. WHEN THIS OCCURRED, THEY WOULD HAVE TO RESTART THE MONITOR. THE PUMP UNIT WAS RULED OUT AS A SUSPECT DEVICE AS WHEN IT WAS REPLACED THE ISSUE STILL OCCURRED. THE CLEARSIGHT MODULE WAS REPLACED FOR A DIFFERENT ONE AND THEN EVERYTHING WORKED WITHOUT FURTHER INCIDENT. THERE IS NO PHYSICAL DAMAGE SEEN ON THE MODULE. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT ADMINISTERED. THE PATIENT DEMOGRAPHICS WERE REQUESTED AND NOT PROVIDED. THERE IS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21260972 ↗
• MalfunctionJan 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED DURING USE THAT THERE WERE INACCURATE BLOOD PRESSURE VALUES WITH THE CLEARSIGHT MODULE. THE DISPLAYED NUMBERS WERE 20 TO 40 POINTS DIFFERENT FROM THE BLOOD PRESSURE CUFF READING. THE CLEARSIGHT READING WOULD STOP AND A FAULT MESSAGE OF "PUMP MALFUNCTION" WAS DISPLAYED. WHEN THIS OCCURRED THEY WOULD HAVE TO RESTART THE MONITOR. THE PUMP UNIT WAS RULED OUT AS A SUSPECT DEVICE AS WHEN IT WAS REPLACED THE ISSUE STILL OCCURRED. THE CLEARSIGHT MODULE WAS REPLACED FOR A DIFFERENT ONE AND THEN EVERYTHING WORKED WITHOUT FURTHER INCIDENT. THERE IS NO PHYSICAL DAMAGE SEEN ON THE MODULE. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT ADMINISTERED. THE PATIENT DEMOGRAPHICS WERE REQUESTED AND NOT PROVIDED. THERE IS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21260960 ↗
• MalfunctionJan 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED DURING USE THAT THERE WERE INACCURATE BLOOD PRESSURE VALUES WITH THE CLEARSIGHT MODULE. THE DISPLAYED NUMBERS WERE 20 TO 40 POINTS DIFFERENT FROM THE BLOOD PRESSURE CUFF READING. THE CLEARSIGHT READING WOULD STOP AND A FAULT MESSAGE OF "PUMP MALFUNCTION" WAS DISPLAYED. WHEN THIS OCCURRED THEY WOULD HAVE TO RESTART THE MONITOR. THE PUMP UNIT WAS RULED OUT AS A SUSPECT DEVICE AS WHEN IT WAS REPLACED THE ISSUE STILL OCCURRED. THE CLEARSIGHT MODULE WAS REPLACED FOR A DIFFERENT ONE AND THEN EVERYTHING WORKED WITHOUT FURTHER INCIDENT. THERE IS NO PHYSICAL DAMAGE SEEN ON THE MODULE. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT ADMINISTERED. THE PATIENT DEMOGRAPHICS WERE REQUESTED AND NOT PROVIDED. THERE IS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21260900 ↗
• MalfunctionJan 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED DURING USE THAT THERE WERE INACCURATE BLOOD PRESSURE VALUES WITH THE CLEARSIGHT MODULE. THE DISPLAYED NUMBERS WERE 20 TO 40 POINTS DIFFERENT FROM THE BLOOD PRESSURE CUFF READING. THE CLEARSIGHT READING WOULD STOP AND A FAULT MESSAGE OF "PUMP MALFUNCTION" WAS DISPLAYED. WHEN THIS OCCURRED, THEY WOULD HAVE TO RESTART THE MONITOR. THE PUMP UNIT WAS RULED OUT AS A SUSPECT DEVICE AS WHEN IT WAS REPLACED THE ISSUE STILL OCCURRED. THE CLEARSIGHT MODULE WAS REPLACED FOR A DIFFERENT ONE AND THEN EVERYTHING WORKED WITHOUT FURTHER INCIDENT. THERE IS NO PHYSICAL DAMAGE SEEN ON THE MODULE. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT ADMINISTERED. THE PATIENT DEMOGRAPHICS WERE REQUESTED AND NOT PROVIDED. THERE IS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21260829 ↗
• MalfunctionJan 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED DURING USE THAT THERE WERE INACCURATE BLOOD PRESSURE VALUES WITH THE CLEARSIGHT MODULE. THE DISPLAYED NUMBERS WERE 20 TO 40 POINTS DIFFERENT FROM THE BLOOD PRESSURE CUFF READING. THE CLEARSIGHT READING WOULD STOP AND A FAULT MESSAGE OF "PUMP MALFUNCTION" WAS DISPLAYED. WHEN THIS OCCURRED, THEY WOULD HAVE TO RESTART THE MONITOR. THE PUMP UNIT WAS RULED OUT AS A SUSPECT DEVICE AS WHEN IT WAS REPLACED THE ISSUE STILL OCCURRED. THE CLEARSIGHT MODULE WAS REPLACED FOR A DIFFERENT ONE AND THEN EVERYTHING WORKED WITHOUT FURTHER INCIDENT. THERE IS NO PHYSICAL DAMAGE SEEN ON THE MODULE. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT ADMINISTERED. THE PATIENT DEMOGRAPHICS WERE REQUESTED AND NOT PROVIDED. THERE IS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21260775 ↗
• MalfunctionJan 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED DURING USE THAT THERE WERE INACCURATE BLOOD PRESSURE VALUES WITH THE CLEARSIGHT MODULE. THE DISPLAYED NUMBERS WERE 20 TO 40 POINTS DIFFERENT FROM THE BLOOD PRESSURE CUFF READING. THE CLEARSIGHT READING WOULD STOP AND A FAULT MESSAGE OF "PUMP MALFUNCTION" WAS DISPLAYED. WHEN THIS OCCURRED, THEY WOULD HAVE TO RESTART THE MONITOR. THE PUMP UNIT WAS RULED OUT AS A SUSPECT DEVICE AS WHEN IT WAS REPLACED THE ISSUE STILL OCCURRED. THE CLEARSIGHT MODULE WAS REPLACED FOR A DIFFERENT ONE AND THEN EVERYTHING WORKED WITHOUT FURTHER INCIDENT. THERE IS NO PHYSICAL DAMAGE SEEN ON THE MODULE. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT ADMINISTERED. THE PATIENT DEMOGRAPHICS WERE REQUESTED AND NOT PROVIDED. THERE IS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21260453 ↗
• MalfunctionJan 9, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE HEMCSM10 WAS PROVIDING INFORMATION THAT WAS NOT CONSISTENT WITH ANOTHER HEMCSM10 THAT WAS TESTED USING THE SAME MONITOR. THE REP COULD NOT RECALL IF ANY ALARMS OR ERRORS DISPLAYED. THE CUSTOMER DID NOT ACCEPT THE DISPLAYED INFORMATION AND REQUESTED THE REP ASSESS THE TECHNOLOGY AS IT WAS TOO LOW FOR PATIENT CONDITIONS NOR CORRELATED WITH NIBP WNL. THERE WERE NO SIGNS OF PHYSICAL DAMAGE OR POOR MODULE SEATING IN HEM1. THIS WAS DURING USE. THERE WAS NO PATIENT INJURY. NO PATIENT DEMOGRAPHICS WERE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21114175 ↗
• MalfunctionNov 26, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BLOOD PRESSURE WAS LOW WHEN USING A HEMCSM10. THEY EXCHANGED IT WITH THE REPS EQUIPMENT WITH SAME HRS AND CUFF AND THE BLOOD PRESSURE WAS CORRECT. 90/54 WERE THE LOW NUMBERS AND THE EXPECTED WITH THE SWITCH WAS 128/84. NO PATIENT TREATMENT WAS APPLIED BECAUSE THERE WAS ANOTHER BLOOD PRESSURE MONITORING DEVICE PLACED. NO DAMAGE NOTED. THERE IS NO PATIENT INJURY. PATIENT DEMOGRAPHICS WERE UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20789216 ↗
• MalfunctionJul 10, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WAS A FAILURE WITH THE CLEARSIGHT MODULE. THERE WAS A BLOOD PRESSURE READING DISCREPANCY WHEN USING THE CS MODULE DURING USE. TROUBLESHOOTING WAS DONE BY CHECKING THE GE MONITOR, CHECKING THE GE CABLES, AND CHECKING THE NON-INVASIVE BLOOD PRESSURE READING ON THE GE MONITOR AND THEN ASSESSING CALIBRATION. THE DISPOSABLE DEVICES WERE EXCHANGED, BUT THE SAME READING DISCREPANCY OCCURRED. THE CLINICIAN EXCHANGED THE PRESSURE CONTROLLER AND THE HEART REFERENCE SENSOR DEVICES, BUT THE SAME ISSUE STILL OCCURRED. BY PROCESS OF ELIMINATION THE CLEARSIGHT MODULE AND ACUMEN CUFF WERE NOT RULED OUT AS SUSPECT. THIS EVENT OCCURRED THREE OTHER TIMES. THE ACUMEN CUFF REPORT WILL BE SUBMITTED IN A SEPARATE SUBMISSION. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT DEMOGRAPHICS WERE REQUESTED BUT NOT PROVIDED. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19712789 ↗
• MalfunctionJul 10, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WAS A FAILURE WITH THE CLEARSIGHT MODULE. THERE WAS A BLOOD PRESSURE READING DISCREPANCY WHEN USING THE CS MODULE DURING USE. TROUBLESHOOTING WAS DONE BY CHECKING THE GE MONITOR, CHECKING THE GE CABLES, AND CHECKING THE NON INVASIVE BLOOD PRESSURE READING ON THE GE MONITOR AND THEN ASSESSING CALIBRATION. THE DISPOSABLE DEVICES WERE EXCHANGED, BUT THE SAME READING DISCREPANCY OCCURRED. THE CLINICIAN EXCHANGED THE PRESSURE CONTROLLER AND THE HEART REFERENCE SENSOR DEVICES, BUT THE SAME ISSUE STILL OCCURRED. BY PROCESS OF ELIMINATION THE CLEARSIGHT MODULE AND ACUMEN CUFF WERE NOT RULED OUT AS SUSPECT. THIS EVENT OCCURRED THREE PREVIOUS TIMES. THE ACUMEN CUFF REPORT WILL BE SUBMITTED IN A SEPARATE SUBMISSION. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT DEMOGRAPHICS WERE REQUESTED BUT NOT PROVIDED. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19711925 ↗
• MalfunctionMay 15, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION WITH THE CLEARSIGHT MODULE, DURING PATIENT USE. THERE WAS AN INCONSISTENCY WITH THE BLOOD PRESSURE READINGS. THEY WERE NOT CORRELATING WITH THE PATIENT'S CONDITION. THE NUMBERS RECEIVED AND WHAT THEY WERE EXPECTED TO BE WERE REQUESTED AND NOT PROVIDED. THEY ATTEMPTED TROUBLESHOOTING, BUT WERE UNABLE TO CORRECT THE ISSUE. THERE IS NO PATIENT INJURY. THERE WAS NO REPORT OF INAPPROPRIATE PATIENT TREATMENT. THE PATIENT DEMOGRAPHICS WERE REQUESTED AND NOT PROVIDED. THE DEVICE HAS BEEN REQUESTED TO BE RETURNED FOR EVALUATION, BUT HAS NOT YET ARRIVED. THE DEVICE HISTORY RECORD REVIEW HAS BEEN COMPLETED AND ALL INSPECTIONS PASSED WITH NO NON-CONFORMANCES. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE PRODUCT EVALUATION RESULTS WHEN AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19326177 ↗
• MalfunctionApr 4, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE HEMCSM10 MEAN ARTERIAL PRESSURE WAS ANYWHERE FROM 20 TO 40 POINTS DIFFERENCE WITH THE LARGEST DISCREPANCY WHEN THE PATIENT WAS HYPERTENSIVE. WHEN THE PATIENT WAS HYPOTENSIVE THE BLOOD PRESSURE FROM THE ACUMEN CUFF WAS WITH 8 MMHG PULSE PRESSURE. DURING THIS TIME THE NONINVASIVE BLOOD PRESSURE WAS UNABLE TO CALCULATE A BLOOD PRESSURE. THE CUFF WAS SIZED CORRECTLY AND PLACED CORRECTLY. THE EVHRS WAS LEVELED AND ZEROED AND AT THE PHLEBOSTATIC AXIS. THERE WERE NO ERROR MESSAGES DISPLAYED. THE HEMOSPHERE WAS GIVING A BLOOD PRESSURE 140 OVER 80 WITH A MEAN OF 90 WHEREAS THE NONINVASIVE BLOOD PRESSURE CUFF WAS GIVING 200 OVER 120. WHEN THE PATIENT WAS HYPOTENSIVE THE BLOOD PRESSURE WAS 46 OVER 38 ON THE HEMOSPHERE. THE REP REPLACED THE CSM MODULE WITH ANOTHER MODULE AND THE BLOOD PRESSURES CORRELATED. THERE WAS NO PATIENT INJURY. THIS WAS DURING USE. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT ADMINISTERED. PATIENT DEMOGRAPHICS WERE UNAVAILABLE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW. THE DEVI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19043636 ↗
• MalfunctionDec 12, 2023Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE HEMCSM10 BLOOD PRESSURE READING IS INCONSISTENT. THE BLOOD PRESSURE READINGS WERE SPORADIC IN THAT THE SYSTOLIC WOULD BECOME LOW THEN INCREASE QUICKLY WITHOUT ANY INTERVENTIONS. IT CONTINUED TO HAPPEN SO STAFF CHECKED PLACEMENT OF THE CUFF MADE SURE NO LINES WERE KINKED AND THE HRS WAS RE-ZEROED. NO DAMAGE WAS NOTED. THIS WAS DURING USE. THERE WAS NO INAPPROPRIATE TREATMENT ADMINISTERED AND PATIENT DEMOGRAPHICS WERE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18314993 ↗
• MalfunctionNov 28, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION WITH THE CLEARSIGHT MODULE, DURING PATIENT USE. THERE WERE INACCURATE BLOOD PRESSURE READINGS THAT OCCURRED. THE READINGS WERE APPROXIMATELY CS BP 160S/30S, THE NIBP 200S/100S THERE WERE NO ERROR MESSAGES THAT DISPLAYED. THE ISSUE WAS ISOLATED TO THE CSM. THERE WAS NO ARTERIAL LINE. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT ADMINISTERED. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT DEMOGRAPHICS ARE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18222573 ↗
• MalfunctionNov 28, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION WITH THE CLEARSIGHT MODULE, DURING PATIENT USE. THERE WERE INACCURATE BP VALUES THAT DISPLAYED. THE CLEARSIGHT BP WAS 160/30 APPROXIMATELY, THE NIBP WAS 200/100 APPROXIMATELY. THERE WERE NO ERROR MESSAGES. THE ISSUE WAS ISOLATED TO THE CS MODULE. THERE WAS NO ARTERIAL LINE. THERE WAS NO INAPPROPRIATE TREATMENT ADMINISTERED. PATIENT DEMOGRAPHICS UNKNOWN. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18222567 ↗
• MalfunctionNov 28, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION WITH THE CLEARSIGHT MODULE, DURING PATIENT USE. THERE WERE INACCURATE VALUES THAT DISPLAYED. THE NIBP WAS IN THE 200S. THE FEMORAL LINE WAS IN THE 180S. THE CLEARSIGHT READING WAS IN THE 90S. THE MALFUNCTION WAS ISOLATED TO THE CLEARSIGHT MODULE. THERE WERE NO ERROR MESSAGES. THE CLINICIANS USED THE FEMORAL LINE VALUE FOR TREATMENT. SQI WAS 3 TO 4 BARS. THERE WAS NO INAPPROPRIATE TREATMENT ADMINISTERED. PATIENT DEMOGRAPHICS UNKNOWN. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18222559 ↗
• MalfunctionMay 15, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE HEMCSM10 SYSTOLIC BLOOD PRESSURE WAS RUNNING LOW AFTER BEING UPGRADED TO THE CLEAR SIGHT DIASTOLIC FIX. THE DIASTOLIC BLOOD PRESSURE AND MEAN ARTERIAL PRESSURE VALUES WERE IN AGREEMENT. THERE WERE NO ERROR MESSAGES. THEY ENSURED SET UP AND ZERO WERE APPROPRIATE IN COMPARISON TO THE A LINE. THERE WAS NO PATIENT INJURY. NO INAPPROPRIATE PATIENT TREATMENT WAS ADMINISTERED AND PATIENT DEMOGRAPHICS WERE UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16934521 ↗
• MalfunctionMar 6, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WERE INACCURATE BLOOD PRESSURE READINGS THAT DISPLAYED WITH THE CLEARSIGHT MODULE. DURING PATIENT USE. THE SYSTEM MONITORING EQUIPMENT WAS SETUP BY THE EDWARDS REPRESENTATIVE. THE PATIENTS BLOOD PRESSURE READING WHEN MONITORING THE NIBP WAS SYSTOLIC 240. THE RADIAL ARTERIAL LINE READING WAS SYSTOLIC 220. THE AIQ CUFF BLOOD PRESSURE READING WAS SYSTOLIC 130 TO 150. THE EDWARDS REPRESENTATIVE WAS PRESENT AND ASKED TO RECYCLE THE BP. THE PATIENT PLACEMENT FOR ALL THREE WERE ON THE SAME EXTREMITY, RIGHT ARM. THE PROCEDURE WAS A CEA. DURING THE PROCEDURE THERE WAS SQUIRTING OF BLOOD FROM THE CAROTID ARTERY. THE BLOOD LOSS QUANTITY ESTIMATION IS 200ML. THERE WAS NO TREATMENT FOR THE BLOOD LOSS. THE PATIENTS POST OPERATIVE CONDITION WAS FINE,. THERE WAS NO PATIENT HARM OR INJURY. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT ADMINISTERED. PATIENT IS FEMALE, NO OTHER DEMOGRAPHICS AVAILABLE. THE REP RECEIVED A REPLACEMENT CLEARSIGHT MODULE AND USED IT FOR ANOTHER CASE AND THERE WERE NO FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16492009 ↗
• MalfunctionMar 6, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WAS A FAILURE WITH THE CLEARSIGHT MODULE, DURING PATIENT USE. THE AIQ CUFF WAS BEING USED TO MONITOR THE PATIENT'S BLOOD PRESSURE READING. THE READING WAS TEN POINTS OFF WHEN COMPARED TO THE NIPB MEASUREMENT. THE EXACT READING OF WHAT WAS DISPLAYED AND WHAT WAS EXPECTED IS NOT AVAILABLE. THE ISSUE WAS ISOLATED TO THE CLEARSIGHT MODULE. WHEN THEY RECEIVED A REPLACEMENT CLEARSIGHT MODULE THEY USED IT WITH THE SAME OTHER EQUIPMENT AND EVERYTHING WORKED AS INTENDED. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT ADMINISTERED. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT DEMOGRAPHICS WERE REQUESTED AND ARE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16491983 ↗