HemoSphere Alta ALTAALL1Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00690103217957), received between Nov 11, 2024 and Mar 17, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (12 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026High Readings

  AS REPORTED, DURING USE IN A LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTATION PROCEDURE OF THIS HEMOSPHERE ALTA MONITOR CONNECTED TO A SWAN-GANZ IQ CATHETER, THE RIGHT VENTRICLE CARDIAC OUTPUT (RVCO) VALUES OF 7.3 L/MIN PROVIDED WERE INCONSISTENT WITH PATIENT'S CLINICAL CONDITION. THEN, A BOLUS THERMODILUTION WAS PERFORMED, OBTAINING AN INTERMITTENT CARDIAC OUTPUT (ICO) VALUE OF 4.3 L/MIN. THE FOLLOWING DAY, RVCO WAS RECALIBRATED, AND THE VALUES WERE ALIGNED (RVCO = 3.8 L/MIN; ICO = 3.7 L/MIN). RVCO REMAINED RELIABLE AFTER THIS CALIBRATION. THERE WERE NO CONSEQUENCES FOR PATIENT, AS PHYSICIAN JUDGEMENT WAS USED TO GUIDE THERAPY. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615913 ↗
• MalfunctionFeb 4, 2026Low Readings

  AS REPORTED, DURING A LIVER TRANSPLANT PROCEDURE IN A HYPERDYNAMIC PATIENT, THE HEMOSPHERE ALTA MONITOR CONNECTED TO A SWAN-GANZ IQ CATHETER DISPLAYED RIGHT VENTRICLE CARDIAC OUTPUT (RVCO) AROUND 3 L/MIN, ASSESSED AS LOW COMPARED TO INTERMITTENT CARDIAC OUTPUT (ICO), WHICH WAS 6 L/MIN. INTERMITTENT CO MEASUREMENTS WERE MORE CLINICALLY CONSISTENT WITH THE PATIENT'S CONDITION. RIGHT VENTRICLE PRESSURE WAVEFORM AND SWAN-GANZ CATHETER POSITION WERE CONSIDERED CORRECT. THE SAME ISSUE OCCURRED IN THE INTENSIVE CARE UNIT (ICU) THE FOLLOWING DAY WITH THE SAME PATIENT. PATIENT MANAGEMENT WAS GUIDED BY THE VALUES DEEMED MOST CLINICALLY APPROPRIATE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. PATIENT DEMOGRAPHIC INFORMATION WAS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256442 ↗
• MalfunctionNov 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, DURING USE, THE BLOOD PRESSURE (BP) READINGS OBTAINED FROM AN ALTA MONITOR WERE INCONSISTENT AND NOT CORRELATING WITH THE NON-INVASIVE BLOOD PRESSURE CUFF OR INVASIVE ARTERIAL LINE. MEAN ARTERIAL PRESSURE (MAP) VALUES, SYSTOLIC, AND DIASTOLIC VALUES WERE OFTEN VASTLY INACCURATE, EITHER MUCH HIGHER OR LOWER. PER REPRESENTATIVE, "THIS DISCREPANCY HAS OCCURRED REPEATEDLY SEVERAL TIMES PER DAY ACROSS MULTIPLE CASES AND APPEARS TO RESOLVE ONLY WHEN THE PATIENT MONITOR IS ZEROED BEFORE ACUMEN IQ FINGER CUFF APPLICATION." THERE WERE NO ALLEGATIONS OF PATIENT INJURIES. ISSUE OCCURRED AT OTHER HOSPITALS. FURTHER INFORMATION WAS NOT PROVIDED. IT IS UNKNOWN HOW MANY HOSPITALS AND MONITORS WERE AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23589476 ↗
• MalfunctionNov 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, DURING USE, THE BLOOD PRESSURE (BP) READINGS OBTAINED FROM AN ALTA MONITOR WAS SIGNIFICANTLY INCONSISTENT AND NOT CORRELATING WITH THE NON-INVASIVE BLOOD PRESSURE CUFF OR INVASIVE ARTERIAL LINE. MEAN ARTERIAL PRESSURE (MAP) VALUES, SYSTOLIC, AND DIASTOLIC VALUES WERE OFTEN VASTLY INACCURATE, EITHER MUCH HIGHER OR LOWER. PER REPRESENTATIVE, "THIS DISCREPANCY APPEARS TO RESOLVE ONLY WHEN THE PATIENT MONITOR IS ZEROED BEFORE ACUMEN IQ FINGER CUFF APPLICATION." THE FOLLOWING TROUBLESHOOTING WAS COMPLETED: VERIFIED CORRECT PATIENT CONNECTION AND PROPER CUFF PLACEMENT PER IFU, RECONNECTED FINGER CUFF AND RESTARTED THE MONITOR, COMPARED ACUMEN IQ READINGS TO NIBP AND/OR A-LINE READINGS, AND OBSERVED THAT ZEROING THE PATIENT MONITOR PRIOR TO CONNECTING IMPROVES CORRELATION TEMPORARILY WITH THE ALTA MONITOR. THERE WERE NO ALLEGATIONS OF PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23589333 ↗
• MalfunctionOct 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE ALTA ALL IN ONE, AN UNPROMPTED HIGH-PITCHED ALARM OCCURRED DURING THE CASE. THE TOUCHSCREEN FROZE, ARTERIAL LINE PRESSURE DISAPPEARED FROM THE ANESTHESIA MONITOR, AND SVO2 READ APPROXIMATELY 30 POINTS LOWER THAN EXPECTED. REBOOTING THE MONITOR RESTORED FUNCTION, BUT THE SVO2 READING REMAINED INACCURATE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23352285 ↗
• MalfunctionAug 20, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, DURING USE, AN ALTA MONITOR DISPLAYED INACCURATE CARDIAC OUTPUT, STROKE VOLUME, CENTRAL VENOUS PRESSURE, STO2, AND SYSTEMIC VASCULAR RESISTANCE VALUES. THE MONITOR ALERTS WERE NOT AUDIBLE EVEN THOUGH IT WAS ACTIVATED IN THE SETTINGS AND NO ALERTS WERE DISPLAYED. ISSUE WAS RESOLVED BY RESTARTING THE MONITOR. THERE WERE NO ALLEGATION OF PATIENT INJURIES. PATIENT DEMOGRAPHICS ARE NOT AVAILABLE. FURTHER INFORMATION IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22856503 ↗
• MalfunctionAug 8, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING THIS TARGET MARKET RELEASE (TMR) ON A TRICUSPID VALVE AND MITRAL VALVE RECONSTRUCTION WITH LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE OF THIS HEMOSPHERE ALTA MONITOR, THE SECOND TIME THE ICO AND CORV WERE MEASURED, THE ICO WAS 3.4 AND THE CORV 1.8. THERE WAS NO ERROR MESSAGES DISPLAYED. THE PATIENT WAS NOT TREATED ACCORDING TO THE INACCURATE VALUES PROVIDED. PATIENT DEMOGRAPHICS WERE NOT AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THERE WILL BE NO PRODUCT RETURN AS THIS IS A TMR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22747835 ↗
• MalfunctionAug 6, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING THIS TARGET MARKET RELEASE (TMR) ON A MITRAL VALVE REPLACEMENT WITH PSEUDOANEURYSM CASE, THE TOTAL HEMOGLOBIN (THB) VALUE WAS HIGHER (10.7 G/DL) ON THE HEMOSPHERE ALTA MONITOR WHEN COMPARED TO THE VALUE OBTAINED FROM THE BLOOD GAS SAMPLE (7.9 G/DL). THE VALUES TREND REMAINED STRAIGHT AND CONSTANT DURING THE WHOLE PROCEDURE EVEN IF THE SENSOR MAY NOT STICK PERFECTLY. AFTER RECALIBRATING THE MONITOR, THB VALUES MATCHED TO THE ONES PROVIDED BY THE BLOOD GAS. THERE WAS NO ERROR MESSAGE DISPLAYED. THE PATIENT WAS NOT TREATED ACCORDING TO THE INACCURATE VALUES. THERE WAS NO PATIENT MOVEMENT. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION SINCE THIS IS A TMR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727685 ↗
• MalfunctionJul 31, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING THIS TARGET MARKET RELEASE (TMR) ON A LVAD- HEARTMATE PROCEDURE, THE SCREEN OF THIS HEMOSPHERE ALTA MONITOR FAILED AS THE DPDT VALUE WAS SIGNIFICANTLY DIFFERENT FROM THE ALTA MONITOR THAN FROM THE ECHO. ALSO, AFTER BYPASS, THE ICO (1.6) WAS LOWER THAN THE CORV (3.0). AFTER CALIBRATION, THE ICO WAS MORE STABLE. THERE WAS NO ERROR MESSAGES DISPLAYED. THE PATIENT WAS NOT TREATED ACCORDING TO THE INACCURATE VALUES PROVIDED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE MONITOR WILL NOT BE RETURNED AS THIS IS A TMR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22673571 ↗
• MalfunctionJul 31, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING THIS TARGET MARKET RELEASE (TMR) ON A MITRAL VALVE & TRICUSPID VALVE REPLACEMENT PROCEDURE, THIS HEMOSPHERE ALTA MONITOR DISPLAYED A MUCH HIGHER ICO (INTERMITTENT CARDIAC OUTPUT) (3.1) THAN CORV (CARDIAC OUTPUT RIGHT VENTRICLE) (2.1). IN ADDITION, THE RV DP/DT VALUE WAS MUCH LOWER (200) THAN ECHO ON THE TEE (TRANSESOPHAGEAL ECHOCARDIOGRAPHY) (700). MOREOVER, IN NON-PULSATILE MODE, THE CEREBRAL ADAPTATIVE INDEX (CAI) WAS INTERMITTENTLY AND INCONSISTENTLY HIGHER THAN 45 NOT DEPENDING ON PROCEDURE, ALTHOUGH MOST OF THE TIME WAS BELOW 45. THERE WAS NO ERROR MESSAGES DISPLAYED. THE PATIENT WAS NOT TREATED ACCORDING TO THE INACCURATE VALUES PROVIDED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THERE WILL BE NO PRODUCT RETURN AS THIS IS A TMR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22673544 ↗
• MalfunctionJul 14, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING THIS ALTA TARGET MARKET RELEASE (TMR) USING A SWAN-GANZ IQ CATHETER, THE DPDT RV VALUE (111 MMHG/S) WAS MUCH LOWER THAN THE DPDT OBTAINED USING THE ECHO TO GRAPH THE WAVEFORM OF THE RV (699 MMHG/S). THERE WAS NO ALLEGATION OF PATIENT INJURY. THERE WILL BE NO PRODUCT RETURN AS THIS IS A TMR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22493448 ↗
• MalfunctionJun 19, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING THIS ALTA TARGET MARKET RELEASE (TMR), THE SETTINGS WERE INCORRECTLY DONE SINCE THE BEGINNING OF THE PROCEDURE; THEREFORE, THE MEAN ARTERIAL PRESSURE(MAP) WAVEFORM AND VALUES WERE LABELED AS CENTRAL VENOUS PRESSURE(CVP) AND THE OTHER WAY AROUND. IN THE BEDSIDE MONITOR BOTH WAVEFORMS WERE CORRECTLY BEING DISPLAYED. SMART WEDGE FEATURE WAS NOT SHOWN AS NOT ACTIVATED. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22291260 ↗
• MalfunctionMar 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED, THAT DURING USE, THE MAP ON THE CAI TILE DISPLAYED ON THIS HEMOSPHERE ALTA MONITOR WAS INACCURATE. THE MAP DISPLAYED IN THE MAP PARAMETER TILE WAS AROUND 85 WHILE CAI MAP WAS 44. THE CAI MAP DID UPDATE AND CHANGE OVER TIME BUT CONTINUED TO STAY AROUND HALF OF THE EXPECTED MAP VALUE. THIS ISSUE OCCURRED AFTER THE PRESSURE CABLE BECAME INADVERTENTLY DISCONNECTED, DURING CARDIOPULMONARY BYPASS. TO TROUBLESHOOT, THE REP ATTEMPTED TO DISCONNECTING & RECONNECTING ALL CABLE CONNECTIONS WITH NO SUCCESS. THERE WAS NO PATIENT INJURY AND THE DEVICE WILL NOT BE RETURNED AS IT IS STILL IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21619855 ↗
• MalfunctionJan 30, 2025Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback

  AS REPORTED, DURING USE IN ICU PATIENT WITH A SWAN-GANZ CATHETER DURING TARGET MARKET RELEASE (TMR) AND WHEN CO, SV, CVP, STO2, SVR VALUES WERE OUT OF RANGE (IN THE RED ZONE), THE ALERTS OF THIS HEMOSPHERE ALTA MONITOR WERE NOT AUDIBLE EVEN THOUGH THE WERE ACTIVATED IN SETTINGS. THE ISSUE WAS SOLVED BY RESTARTING THE MONITOR. IN ADDITION, THERE WAS NO ALERT AFTER ZEROING. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT AVAILABLE. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION SINCE IT IS TMR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21276183 ↗
• MalfunctionDec 12, 2024No Device Output; No Device Output

  AS REPORTED, DURING THIS TARGET MARKET RELEASE (TMR) , IN THIS ALTA MONITOR, THE CLINICIAN WAS USING THE GESTURE FEATURE, BUT THE MONITOR UNDERSTOOD HE WAS SILENCING ALARMS WHEN HE WAS NOT. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20913182 ↗
• MalfunctionNov 22, 2024Infusion or Flow Problem; Infusion or Flow Problem

  AS REPORTED, DURING THIS TARGET MARKET RELEASE (TMR), IN THIS HEMOSPHERE ALTA MONITOR, THE LACTATED RINGERS BOLUS ADMINISTERED WITH THE AFM WAS TRACKED WITH DELAY. THEREFORE, SV (STROKE VOLUME) VALUE AND BLUE LINE TREND ON THE 10-TREND SCREEN WAS NOT UPDATED AND DID NOT REFLECT VOLUME CHANGES IN PATIENT. IT WAS CORRECTLY TRACKED IN THE CLINICAL TOOLS SCREEN AND THERE WAS NO MORE BOLUS ADMINISTERED AS CONSEQUENCE OF THIS ISSUE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THERE WILL BE NO PRODUCT RETURN AS THIS IS A TMR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20757455 ↗
• MalfunctionNov 21, 2024Incorrect Measurement; Incorrect Measurement

  AS REPORTED, N NON-PULSATILE MODE WITH THIS HEMOSPHERE ALTA MONITOR DURING THIS TARGET MARKET RELEASE (TMR), CEREBRAL ADAPTATIVE INDEX (CAI) TILE WAS INACCURATE SINCE IT WAS NOT UPDATED WITH THE LIVE MAP VALUE, EVEN IF THE LIVE MAP VALUE WAS CORRECTLY DISPLAYED ON THE MONITOR. THERE WAS NO ALARM NOR ERROR MESSAGE DISPLAYED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THERE WILL BE NO PRODUCT RETURN AS THIS IS A TMR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20746358 ↗
• MalfunctionNov 20, 2024Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING THIS TARGET MARKET RELEASE (TMR) WITH THIS HEMOSPHERE ALTA MONITOR, IN A PATIENT IN BYPASS (NON PULSATILE MODE), CEREBRAL ADAPTATIVE INDEX (CAI) MAP VALUE DURING BYPASS (IN NON-PULSATILE MODE) WAS INACCURATE AND DID NOT CORRELATE WITH THE MAP READINGS FROM THE ARTERIAL LINE. ADDITIONALLY, CLINICIAN SAID DURING THE NIGHT THERE WAS A DISCREPANCY OF APPROXIMATELY 2 G/DL BETWEEN THE THB DISPLAYED AND THE ACTUAL THB. THE PARAMETER WAS STILL SHOWING "CAL" HAS IT HAD BEEN PREVIOUSLY CALIBRATED; ALTHOUGH THE CLINICIAN STATED THAT THE RECALIBRATION FLAG INDICATING A RECALIBRATION NEEDED HAD NOT BEEN SHOWN PREVIOUSLY. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20732707 ↗
• MalfunctionNov 14, 2024Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING THIS TARGET MARKET RELEASE (TMR) WITH THIS HEMOSPHERE ALTA MONITOR IN A PATIENT IN BYPASS (NON PULSATILE MODE WITH PUMP PRESSURE MAINTAINED AT 58-60 MMHG ALL THE PROCEDURE), CEREBRAL ADAPTATIVE INDEX (CAI) TILE WAS HIGH (REMAINED IN 70 WITH MINOR FLUCTUATIONS) SINCE IT WAS NOT UPDATED WITH THE LIVE MAP VALUE. THE LIVE MAP VALUE WAS CORRECTLY DISPLAYED ON THE MONITOR ALL THE TIME. THIS PROBLEM IS NOT EXPERIENCED WHEN PATIENT IS NOT ON BYPASS (PULSATILE MODE); AFTER NON PULSATILE MODE WAS DISABLED, THE MAP REPORTED ON CAI WAS MORE REALIGNED WITH LIVE MAP VALUE. THERE WAS NO ALARM NOR ERROR MESSAGE DISPLAYED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20681720 ↗
• MalfunctionNov 11, 2024Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING THE TARGET MARKET RELEASE (TMR) WITH THIS HEMOSPHERE ALTA MONITOR IN A PATIENT IN BYPASS (NON PULSATILE MODE), CEREBRAL ADAPTATIVE INDEX (CAI) VALUE TILE IS HIGH SINCE IT IS NOT UPDATED WITH THE LIVE MAP VALUE, EVEN IF THE LIVE MAP VALUE IS CORRECTLY DISPLAYED ON THE MONITOR. THERE WAS NO ALARM NOR ERROR MESSAGE DISPLAYED. THIS PROBLEM IS NOT EXPERIENCED WHEN PATIENT IS NOT ON BYPASS (PULSATILE MODE). THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20651257 ↗
• MalfunctionNov 11, 2024Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING THIS TARGET MARKET RELEASE (TMR), WITH A PATIENT IN BYPASS (NON PULSATILE MODE), WITH THIS ALTA HEMOSPHERE MONITOR, THE CEREBRAL ADAPTATIVE INDEX (CAI) VALUE IN TILE WAS HIGH SINCE IT WAS NOT UPDATED WITH THE 20-SECOND MEAN ARTERIAL PRESSURE (MAP) OR LIVE ABSOLUTE MAP ON THE ARTERIAL WAVEFORM AS INTENDED. THE LIVE MAP VALUE WAS CORRECTLY DISPLAYED ON THE MONITOR. THERE WAS NO ALARM NOR ERROR MESSAGE DISPLAYED. THIS PROBLEM WAS NOT EXPERIENCED WHEN PATIENT WAS NOT ON BYPASS (PULSATILE MODE). THERE WAS NO ALLEGATION OF PATIENT INJURY. THERE DEVICE WAS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20650772 ↗
• MalfunctionNov 11, 2024Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING THE TARGET MARKET RELEASE (TMR) WITH THIS HEMOSPHERE ALTA MONITOR IN A PATIENT IN BYPASS (NON PULSATILE MODE), CEREBRAL ADAPTATIVE INDEX (CAI) TILE IS HIGH SINCE IT IS NOT UPDATED WITH THE LIVE MAP VALUE, EVEN IF THE LIVE MAP VALUE IS CORRECTLY DISPLAYED ON THE MONITOR. THERE WAS NO ALARM NOR ERROR MESSAGE DISPLAYED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THERE WILL BE NO PRODUCT RETURN AS THIS IS A TMR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20650346 ↗