Joerns Bari10ARecalls & reported problems
Joerns Healthcare, LLC · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00857268006011), received between Jul 28, 2025 and Aug 20, 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.
Reports received per month
Most reported problems
Device problems
- Break1
- Unintended Movement1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2025Break; Break
IT WAS REPORTED TO THE MANUFACTURER, BY THE END USER, PER THE END USER, THAT AGILITI WAS CALLED ABOUT A BARIATRIC BED BEING BROKEN AND WERE ASKED FOR A REPLACEMENT BED. AGILITI SAW THAT A WHEEL HAD BROKEN OFF THE FRAME, BROUGHT UP THE REPLACEMENT BED, BUT THE BROKEN BED WAS BLOCKING THE ELEVATOR. AGILITI WENT BACK DOWNSTAIRS TO TRANSFER ELEVATORS, DURING THE TIME, THE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL OWNED BED FRAME. THE PATIENT WAS NOT INJURED BY THE INCIDENT. THE CUSTOMER IS NOT REQUESTING A WRITTEN REPORT. AGILITI WILL BE PERFORMING THE INVESTIGATION. COMPLAINT # (B)(4) WAS ENTERED INTO OUR SYSTEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22853683 ↗InjuryJul 28, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED TO THE MANUFACTURER, BY THE END USER, PER THE END USER, THAT PER OPERATIONS SUPERVISOR HOSPITAL, THE TRANSPORTER WAS TRYING TO PUT THE RIGHT SIDE OF THE BED UP. HE WAS NOT ABLE TO LOCK THE SIDE RAIL INTO PLACE DUE TO THE MATTRESS BEING INFLATED AND THE SIDE EXTENDERS NOT BEING EXTENDED. IT DID MAKE IT HARD TO LOCK INTO PLACE. AT THAT TIME, THE TRANSPORTER WAS STRUCK IN THE HEAD BY THE SIDE RAIL. HE WAS BENT DOWN, AND THE SIDE RAIL DROPPED AND STRUCK HIM CAUSING HIM TO GO TO THE EMERGENCY ROOM FOR TREATMENT. AT THE TIME, THE TRANSPORTER WAS NOT A PATIENT, BUT AFTER THE INCIDENT HE DID BECOME ONE. COMPLAINT (B)(4) WAS ENTERED INTO OUR SYSTEM.
Patient problems: Insufficient Information
MAUDE report 22627011 ↗
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- drive PLTCABLDrive Devilbiss Healthcare · Bariatric bed1 death1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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