EV1000 EVHRSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00690103193374), received between Jan 16, 2024 and Jan 16, 2024 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionJan 16, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WERE INACCURATE VALUES WITH THE HEART REFERENCE SENSOR DURING PATIENT USE. MONITORING WAS INITIATED. THE CS READINGS AND THE NIBP READINGS CORRELATED. THE PATIENT WAS TILTED TO 70 DEGREES AND THE CLEARSIGHT READINGS WERE NOW HIGHER THAN THE NIBP AND THE MAP READINGS. A 40 POINT DIFFERENCE. THE CS MONITORING STOPPED, THE HRS WAS REZEROED WITH PROPER ALIGNMENT. THE HRS WAS AT THE PHLEBOSTATIC ACCESS AND CLIPPED TO THE PATIENT GOWN AND IT DID NOT MOVE. IT WAS FIRST PLACED WHEN THE PATIENT WAS SUPINE. THE HRS WAS THEN REZEROED SUCCESSFULLY WHILE THE PATIENT WAS UPRIGHT. THERE WAS NO PATIENT INJURY. PATIENT DEMOGRAPHICS WAS NOT PROVIDED. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT ADMINISTERED. INFORMATION RECEIVED BY THE CUSTOMER IS THAT THIS HAS OCCURRED PREVIOUSLY OVER THE LAST FEW MONTHS, EXACT NUMBER IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18522492 ↗
• MalfunctionJan 16, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WERE INACCURATE VALUES WITH THE HEART REFERENCE SENSOR DURING PATIENT USE. MONITORING WAS INITIATED. THE CS READINGS AND THE NIBP READINGS CORRELATED. THE PATIENT WAS TILTED TO 70 DEGREES AND THE CLEARSIGHT READINGS WERE NOW HIGHER THAN THE NIBP AND THE MAP READINGS. A 40 POINT DIFFERENCE. THE CS MONITORING STOPPED, THE HRS WAS REZEROED WITH PROPER ALIGNMENT. THE HRS WAS AT THE PHLEBOSTATIC ACCESS AND CLIPPED TO THE PATIENT GOWN AND IT DID NOT MOVE. IT WAS FIRST PLACED WHEN THE PATIENT WAS SUPINE. THE HRS WAS THEN REZEROED SUCCESSFULLY WHILE THE PATIENT WAS UPRIGHT. THERE WAS NO PATIENT INJURY. PATIENT DEMOGRAPHICS WAS NOT PROVIDED. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18522432 ↗