EV1000 PC2KRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00690103193473), received between Feb 14, 2022 and Sep 15, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (8 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 10 most recent of 10 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 Pressure Controller it gave inaccurate readings. There was no allegation of patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774245 ↗
• MalfunctionSep 15, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that during use of the Pressure Controller it gave inaccurate readings. There was no allegation of patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774238 ↗
• MalfunctionAug 14, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED, THIS PC2K CABLE DID NOT REACH THE EXPECTED VALUES. IN ADDITION, A HISS COULD BE HEARD FROM THE MODULE. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS HAVE BEEN REQUESTED. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22803670 ↗
• MalfunctionJun 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, DURING USE, THE STAFF NOTICED A BLOOD PRESSURE (BP) DIFFERENCE BETWEEN THE CLEARSIGHT AND NON-INVASIVE BLOOD PRESSURE. THE CLEARSIGHT CONSISTENTLY SHOWED LOW MEAN ARTERIAL PRESSURE (MAP) VS. SIMULTANEOUS NON-INVASIVE BLOOD PRESSURE. IT WAS CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22322408 ↗
• MalfunctionJun 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING SET UP OF THE PRESSURE CONTROLLER KIT, IT WAS GIVING INCONSISTENT READINGS. THE REP EXCHANGED THE DEVICE FOR A NEW ONE AND THE ISSUE RESOLVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22136725 ↗
• MalfunctionMar 7, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING A DEMONSTRATION, THIS PC2K PROVIDED INCORRECT CARDIAC OUTPUT (CO), STROKE VOLUME VARIATION (SVV) AND SYSTEMIC VASCULAR RESISTANT (SVR) VALUES. ALSO, HYPOTENSION PREDICTION INDEX (HPI) WAS CONSTANTLY ALERTING. THERE WAS NO ERROR MESSAGE DISPLAYED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21544383 ↗
• 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 PC2K. 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 20789181 ↗
• 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 PRESSURE CONTROLLER, 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 19326206 ↗
• MalfunctionOct 18, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PC2K NUMBERS ON THE HEM1 WERE JUMPING AROUND WHILE USING CLEARSIGHT. THEY EXCHANGED THE SUSPECT PC2K AND THE ISSUE WAS CORRECTED. THIS WAS DURING USE. THERE IS NO PATIENT INJURY. PATIENT DEMOGRAPHICS WERE UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17961657 ↗
• MalfunctionFeb 14, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT ONE OF THE PC2K CUFFS IS NOT WORKING. THE PATIENT CUFF IS READING A BLOOD PRESSURE OF 130 OVER 80 BUT THIS PC2K IS SHOWING A LOW READING OF 90 OVER 60. THE CLINICIAN EXCHANGED TO A KNOWN WORKING PC2K USING THE SAME MONITOR AND ACCESSORIES AND EVERYTHING WORKS. THIS WAS DURING USE. THERE IS NO PATIENT INJURY. THERE WERE NO ERROR MESSAGES. PATIENT DEMOGRAPHICS WERE UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13529463 ↗