Direct Supply 1070014BEIRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00817492011618), received between Jan 7, 2025 and Mar 27, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Human-Device Interface 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2025Human-Device Interface Problem; Human-Device Interface Problem

  CUSTOMER REPORTED THE ARM WITH THE WHEEL ON IT BECAME SEPARATED FROM THE FRAME, CAUSING THE HEAD OF THE BED TO COME CRASHING DOWN. CUSTOMER DID NOT REPORT A PATIENT IN THE BED. WE ARE SENDING A NEW LEG AND REQUESTING THE LEG IN QUESTION BE RETURNED FOR INVESTIGATION TO DETERMINE IF A MALFUNCTION OCCURED. WE ARE REPORTING WITH THE INFORMATION PROVIDED OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21708862 ↗
• MalfunctionFeb 26, 2025Human-Device Interface Problem; Insufficient Device Problem Information; Human-Device Interface Problem; Insufficient Device Problem Information

  CUSTOMER REPORTED THE ARM WITH THE WHEEL ON IT BECAME SEPARATED FROM THE FRAME. CUSTOMER LATER REPORTED A PATIENT WAS IN THE BED AT THE TIME BUT THEY WERE NOT INJURED. CUSTOMER DECLINED TO GIVE PATIENT DETAILS. WE ARE SENDING A NEW LEG AND REQUESTING THE LEG IN QUESTION BE RETURNED FOR INVESTIGATION TO DETERMINE IF A MALFUNCTION OCCURED. WE ARE REPORTING WITH THE INFORMATION PROVIDED OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21468511 ↗
• MalfunctionJan 7, 2025Human-Device Interface Problem; Insufficient Device Problem Information; Human-Device Interface Problem; Insufficient Device Problem Information

  (B)(4). AT 3:23 PM ON (B)(6)2024, (B)(6) CALLED TO REPORT AN INCIDENT THAT ALLEGEDLY INVOLVED THE FOLLOWING PRODUCT OR DEVICE: BED. (B)(6) REPORTED THAT THE FOLLOWING OCCURRED: (B)(6) SAID SHE WAS TOLD THE RESIDENT SAID THEY GOT WHIPLASH WHEN THE HEAD OF THE BED GAVE OUT. IT IS UNKNOWN HOW MANY PEOPLE WERE PRESENT DURING THE INCIDENT. THE INITIAL REPORT WAS RECEIVED AND STAFF LEFT 3 MESSAGES AND SHE HAD NOT CALLED BACK BY THURS. (B)(6)2024 9:38AM. ON (B)(6)2024 10:47AM WE WERE NOTIFIED OF THE INCIDENT AND THAT THEY WERE ABLE TO CONTACT HER. THE RESPONSE WAS THAT MAINTENANCE FIXED THE ISSUE BUT DIDN'T KNOW HOW IT WAS POSSIBLE TO COME OUT OF THE TRACK. SHE IS A BARIATRIC PATIENT WEIGHT IS 396 LBS. THEY DID NOT REPORT THAT SHE WAS TAKEN FOR TREATMENT OR PROVIDE ANY MEDICAL RECORDS FOR THE ALLEGED WHIPLASH. NO PICTURES OR VIDEOS WERE PROVIDED. THERE WAS LITTLE RESPONSE FROM THE CUSTOMER SO WE SENT A REPLACEMENT BED AND REQUESTED THE BED IN QUESTION BE RETURNED FOR INVESTIGATION. AT THE TIME OF THIS REPORT, THE BED HAS NOT RETURNED FOR INVESTIGATION AND COULD NOT DETERMINE IF IT MALFUNCTIONED. REPORT IS BEING FILED AFTER THE 30 DAY TIMELINE DUE TO CONFUSION REGARDING THE REPORTING OF MD

  Patient problems: Neck Pain

  MAUDE report 21093248 ↗