WeCare Response Bed PAN1000-FLEX-RILRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810055883066), received between Feb 20, 2025 and Aug 17, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED TO THE MANUFACTURER, BY THE END USER, PER THE END USER, THAT CUSTOMER REACHED OUT REGARDING THE BEDS. THEY HAVE 8 AND "REALLY LIKE THEM BUT ARE CONCERNED" INITIAL REPORT: A RESIDENT TRIED TO USE THE FOOT BOARD TO STEADY HIMSELF BUT THE FOOTBOARD BRACKETS JUST POPPED OUT OF THE SLOT AND THE PANEL FLIPPED THEN THE RESIDENT FELL. ACCORDING TO THE DON, HE NEEDED 21 STITCHES IN HIS KNEE. THE RESIDENT'S WEIGHT IS 148.4 LBS. CUSTOMER NEEDS TO KNOW IF THERE IS SOME WAY TO LOCK DOWN THE FOOTBOARDS SO THEY DO NOT POP OUT OF THE BRACKETS. " THE BED YALL SOLD US, THEY FOUND THE FOOT REST AND HEADBOARD HAVE A BRACKET, IT SLIDES INTO A SLOT. " RESIDENT APPARENTLY USED IT TO BRACE TO GET UP. WHEN THEY PUT WEIGHT AGAINST IT, THE FOOTBOARD TILTED SIDEWAYS AND THE RESIDENT FELL. THEY NEED SOMETHING THAT WILL SECURE THE FOOTBOARD INTO THE BED, WE CANNOT HAVE THAT HAPPEN AGAIN. "HE KNOWS THEY ARE NOT SUPPOSED TO USE IT TO GET UP BUT -IT WILL HAPPEN AGAIN- IF THEY DON'T CHANGE SOMETHING." COMPLAINT #(B)(4) HAS BEEN ENTERED INTO OUR SYSTEM.

  Patient problems: Fall

  MAUDE report 22824546 ↗
• MalfunctionFeb 20, 2025Break; Break

  IT WAS REPORTED TO THE MANUFACTURER, BY THE END USER, PER THE END USER, THAT (B)(6) FORWARDED AN EMAIL FROM (B)(6)"AT 2:30 PM ON (B)(6) 2025, (B)(6) CALLED TO REPORT AN INCIDENT THAT ALLEGEDLY INVOLVED THE FOLLOWING PRODUCT OR DEVICE: BED. (B)(6) REPORTED THAT THE FOLLOWING OCCURRED AT LAST NIGHT ON (B)(6) 2025: CUSTOMER REPORTED THE FOOT END OF THE BED DROPPED QUICKLY WITH A RESIDENT IN IT. (NO INJURY THO). OUR MAINTENANCE TEAM REPLACED THE BED AND THEN INSPECTED THE ISSUE. THE SHAFT IN THE MOTOR THAT RAISES AND LOWERS THE FOOT OF THE END OF THE BED BROKE. THERE WERE NO INJURIES ACCORDING TO (B)(6). THE PRODUCT HAS BEEN TAKEN OUT OF USE. THE RESIDENT'S WEIGHT IS CUSTOMER DID NOT GIVE A WEIGHT BUT SAID THE ONE ITEM THAT WAS CHECKED FIRST WAS THE SAFE WORKING LOAD IS LISTED AT 450LBS AND THE RESIDENT IS WELL UNDER THAT, SO THAT SHOULD NOT BE A FACTOR IN THE PROBLEM. (B)(6). COMPLAINT#: (B)(4) AND RA#: 84096615 WERE ENTERED INTO OUR SYSTEM TO HAVE THE BED RETURNED FOR INVESTIGATION. AS OF THIS WRITING, THE BED HAS NOT BEEN RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21429285 ↗