CompuRecord G.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884838044487), received between Oct 7, 2020 and Oct 7, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Data Problem” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 7, 2020Data Problem

  CUSTOMER REPORTED THAT COMPURECORD DATA WAS INCORRECT. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: Insufficient Information

  MAUDE report 10645085 ↗
• MalfunctionOct 7, 2020Defective Device

  THE CUSTOMER REPORTED THAT COMPURECORD DATA WAS INCORRECT. RECENT FINDINGS THAT A SOFTWARE DEFECT IS THE ROOT CAUSE OF THE INCORRECT COMPURECORD DATA. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10643833 ↗
• MalfunctionOct 7, 2020Data Problem

  THE CUSTOMER REPORTED THAT COMPURECORD DATA WAS INCORRECT. RECENT FINDINGS THAT A SOFTWARE DEFECT IS THE ROOT CAUSE OF THE INCORRECT COMPURECORD DATA. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO PATIENT OR USER WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 10643831 ↗
• MalfunctionOct 7, 2020Data Problem

  CUSTOMER REPORTED THAT COMPURECORD DATA WAS INCORRECT. RECENT FINDINGS THAT A SOFTWARE DEFECT IS THE ROOT CAUSE OF THE INCORRECT COMPURECORD DATA. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO PATIENT OR USER WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 10643677 ↗