EV1000 EV1000ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00690103189650), received between Mar 4, 2022 and Apr 13, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED IN THE EV1000 SYSTEM THAT WHEN CLEARSIGHT STARTS THE SYSTEM GETS TO A GOOD PHYSIOCAL CONTINUES FOR A WHILE AND THEN COMPLETELY STOPS READING AND BEGINS TO RECALIBRATE. IT ACTED AS IF THE CUFF WAS LEAKING BUT THEY SWITCHED OUT SEVERAL CUFFS AND HAD THE SAME OCCURRENCE. THEY ALSO REPORTED THE BLOOD PRESSURES BEING VERY OFF. THE INACCURATE VALUES WERE IN COMPARISON TO A BRACHIAL CUFF. THE MAPS WERE OFF BY MORE THAN 20MMHG THUS MAKING SYS AND DIA EVEN FURTHER APART. CLEARSIGHT WAS READING CLINICALLY LOW WHILE THE CUFF WAS NORMAL. THERE WERE NO CLINICAL SIGNS FOR HYPOTENSION.THIS WAS DURING USE. THERE IS NO PATIENT INJURY. PATIENT DEMOGRAPHICS WERE REQUESTED BUT UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14092334 ↗
• MalfunctionMar 4, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED BY THE BIOMED THAT THERE WERE FLUCTUATING AND INCORRECT VALUES WITH THE EV1000 SYSTEM. WHEN THEY EXCHANGED THE SUSPECT EV1000 SYSTEM FOR ANOTHER ONE, THEN THE ISSUE WAS RESOLVED. THERE WERE NO ERROR MESSAGES PRESENT. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT REPORTED. THE PATIENT DEMOGRAPHICS HAS BEEN REQUESTED, BUT NOT PROVIDED. SEVERAL ATTEMPTS HAVE BEEN MADE TO THE FACILITY FOR ADDITIONAL DETAILS AND NO RESPONSE RECEIVED. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13673390 ↗