EV1000 EVPMPRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103193213), received between Oct 5, 2021 and Oct 5, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K140312, K160552); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 5, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE PUMP UNIT FAILED FUNCTIONAL TEST FOR PRESSURE AT VARIOUS FLOWS WITH THE DIFFERENCE PRESSURE OUTLET AD AT 150 NORMAL LITERS PER HOUR. THE MEASUREMENT IS 136.3 MMHG AND THE LIMITS ARE FROM PLUS OR MINUS 10 MMHG. THE TEST TECHNICIAN FOUND THAT THE PUMPS MANIFOLD BOTTOM HAD CRACKS AROUND THE PEMS FOR THE MANIFOLD LID. ALL TESTS PASSED AFTER THE MANIFOLD BOTTOM WAS REPLACED. THERE WERE NO ERROR MESSAGES OR ALARMS THAT DISPLAYED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12579949 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140312, K160552. One submission often covers many models, so check the product and lot details in each record.

• Z-1193-2019 · Mar 21, 2019 · Terminated
  EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monitor is used to optimize fluid management through the use of minimally invasive monitori
• Z-1732-2015 · May 18, 2015 · Terminated
  ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and ClearSight finger cuffs noninvasively measures blood pressure and associated hemodynamic pa