ACS CDMH06ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00191072029324), received between Feb 4, 2019 and Feb 15, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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.

• MalfunctionFeb 15, 2019Contamination /Decontamination Problem

  AFTER PULLING THE BLUE WRAPPED PACK (ANTERIOR HIP PACK) OUT OF THE CLEAR PACKING A STREAK OF WHAT APPEARED TO BE DRIED BLOOD WAS FOUND ON THE STICKER THAT KEEPS THE BLUE WRAP TOGETHER. THE PACK WAS TAKEN TO THE QUALITY OFFICE. NEW PACK OBTAINED. THIS OCCURRED PRIOR TO THE PATIENT ENTERING THE OPERATING ROOM.

  Patient problems: No Patient Involvement

  MAUDE report 8343099 ↗
• MalfunctionFeb 4, 2019Contamination /Decontamination Problem

  A HAIR WAS FOUND ON THE PLASTIC BLUE BASIN IN THE ANTERIOR HIP PACK (CDMH06E) PRIOR TO THE PATIENT ENTERING THE OPERATING ROOM. THE BASIN AND SUPPLIES WERE THROWN AWAY AND A NEW STERILE FIELD WAS SET UP.

  Patient problems: No Patient Involvement

  MAUDE report 8300775 ↗