DeRoyal 88-000102Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756053297), received between Jul 27, 2018 and Sep 22, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).

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.

• MalfunctionSep 22, 2021Unintended Power Up; Unable to Obtain Readings; Failure to Reset; Unintended Power Up; Unable to Obtain Readings; Failure to Reset

  THE GROUNDING PADS IN THE LOT WERE NOT READING SO A SEPARATE PAD FROM A DIFFERENT LOT NUMBER WAS USED INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Reproductive System or Breast Problem

  MAUDE report 12514419 ↗
• MalfunctionJul 27, 2018Electrical /Electronic Property Problem; Grounding Malfunction; Unintended Electrical Shock; Electrical /Electronic Property Problem; Grounding Malfunction; Unintended Electrical Shock

  THE END USER REPORTED THE GROUNDING PAD IS NOT WORKING PROPERLY. IT CAUSED THE ALARM ON THE UNIT TO ACTIVATE, WHICH THE END USER SPECULATES MAY BE DUE TO NOT MAKING GOOD CONTACT. THE DOCTOR REPORTEDLY FELT A SHOCK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7726719 ↗