Enterprise 9614DF101BCUSBRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05056097337265), received between Nov 17, 2021 and Nov 17, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Unintended Movement” (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. How this data works · Data updated Oct 13, 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.

• InjuryNov 17, 2021Unintended Movement; Unintended Movement

  FOLLOWING THE INFORMATION PROVIDED, THE BACKREST OF THE BED WAS ARTICULATING ON ITS OWN AT TIMES. THERE WAS NO PATIENT INVOLVED WHEN THE MALFUNCTION OCCURRED. NO INJURY WAS SUSTAINED. THE EVALUATION OF THE BED PERFORMED BY THE ARJO ENGINEER ALLOWED TO DETERMINE THAT THE CONTROLLER AND ITS CABLES WERE WORN AS A RESULT OF COMING INTO CONTACT WITH THE PATIENT'S WHEELCHAIR DURING TRANSITION IN AND OUT OF BED. AFTER CONTINUOUS USE THIS WAY, THE PARTS BECAME EXCESSIVELY WORN OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12827501 ↗