Direct Supply 0-99545Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822383549804), received between Feb 9, 2021 and Feb 9, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2021Material Fragmentation; Material Fragmentation

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A BED. THE AFFECTED COMPONENT WAS THE HAND CONTROL. THE DEVICE WAS RETURNED FOR EVALUATION. WE ARE FILING THIS REPORT IN AN OVER-ABUNDANCE OF CAUTION DUE TO AN MDR REGRESSION ANALYSIS. THE CERTIFIED NURSING ASSISTANT WAS ADJUSTING THE BED FOR THE PATIENT WHEN IT REPORTEDLY EXPLODED. THE CNA WAS TAKEN TO THE ER WHERE HE WAS DIAGNOSED WITH A RUPTURED EAR DRUM. THE CONTROL BOX WAS SENT BACK FOR EVALUATION. THE UNIT WAS MODERATELY USED. THE CASE ARRIVED IN BROKEN PIECES. THE CONTROL BOX MAY HAVE BROKEN DUE TO AN APPLIED FORCE ON IT FROM ANOTHER OBJECT. ONE WIRE IN THE CONTROL BOX WAS DETACHED. THERE WAS NO SIGN OF ELECTRONICS EXPLODING. THERE WERE NO UNUSUAL SMELLS. A ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. HISTORICAL DATA FOR COMPLAINT OF THE SAME NATURE WAS REVIEWED SHOWING NO TRENDS. THIS IS CONSIDERED AN ISOLATED INCIDENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11301749 ↗