93H ProFlexx® 0015757Recalls & reported problems
Ferno-Washington, Inc. · 93H ProFlexx®, Red FOF USA · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190790000394), received between Dec 28, 2016 and Dec 28, 2016.
The most frequently reported specific device problem is “Device Maintenance Issue” (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
Device problems
- Device Maintenance Issue1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
Dec 28, 2016Device Maintenance Issue; Device Maintenance Issue
IT WAS REPORTED AFTER LOADING A PATIENT ON THE COT THE MEDICS WERE ALLEGEDLY UNABLE TO RAISE THE COT TO THE TRANSPORT POSITION. THE CREW CALLED ANOTHER MEDIC UNIT TOR TRANSPORT OF THE PATIENT ON ANOTHER COT. THERE WAS NO REPORT OF INJURY OR ADVERSE CONSEQUENCE TO THE PATIENT. THE UNDERCARRIAGE OF THE SUBJECT COT WAS ABLE TO BE EXTENDED WITH FORCE SO IT COULD BE TRANSPORTED BACK TO THE STATION. A FIELD TECHNICIAN WAS ONSITE WHEN THE COT WAS RETURNED TO THE STATION. THE COT WAS EVALUATED AND IT WAS FOUND A WASHER WAS MISSING FROM THE FOOT END COVER PLATE WHICH ALLOWED THE SCREW TO POKE DOWN TOO FAR AND IMPEDE THE TRAVEL OF THE ROLLER. THE MISSING WASHER WAS FOUND TO BE AN OVERSIGHT FROM A PREVIOUS PM SERVICE CONDUCTED ON 12/7/2016. THE WASHER WAS INSTALLED AND THE COT WAS TESTED FOR ALL FUNCTIONS AND RETURNED TO SERVICE ON THE SAME DAY AS THE REPORTED INCIDENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6208374 ↗
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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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