BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANACEA

    MDR report key: 21093248 · Received January 7, 2025

    Report

    Report Number
    1931947-2024-00001
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Date of Event
    August 20, 2024
    Report Date
    October 28, 2024
    Manufacturer
    NOA MEDICAL INDUSTRIES
    Product Code
    FNL
    UDI-DI
    00817492011618
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE TESTS WERE COMPLETED WITH THE MAXIMUM SAFE WORKING LOAD OF 600 LBS. TO SIMULATE WHAT COULD HAVE HAPPENED. THE ONLY WAY TESTING COULD GET THE BED TO FAIL IN THE MANNER DESCRIBED WAS TO STRAP THE CASTER BASE TO THE HEAD END OF THE BED TO SIMULATE THE BED RAISING UNTIL IT HIT AN OBSTRUCTION. THE BED WOULD STOP AND THE OPERATOR WOULD HAVE HAD TO REPEATEDLY PUSH THE UP ELEVATION BUTTON TO GET IT TO MOVE AGAIN RESULTING IN BENDING THE ACTUATOR PIN, ARM AND LEG WHICH RESULTED IN PULLING THE LEGS OUT OF THE TRACK AND THE HEAD END OF THE BED COLLAPSING. THE CUSTOMER WAS ADVISED OF TEST RESULTS AND TO LOOK FOR OBSTRUCTIONS THAT COULD BE IN THE ROOM. WATCH FOR THE BED STOPPING OR ONLY MOVING AT ONE END INDICATING THERE IS AN OBSTRUCTION. SCRATCHES UNDER THE BED INDICATE A LIFT WAS USED OR STORAGE WAS UNDER THE BED. DO NOT STORE ITEMS UNDER THE BED.

    Additional Manufacturer Narrative · 0

    REPORT WILL BE UPDATED AS INFORMATION BECOMES AVAILABLE. REPORTING WITH INFORMATION REASONABLY KNOWN.

    Description of Event or Problem · 0

    (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 MDRS WITH LITTLE INFORMATION. WE ARE REPORTING WITH THE INFORMATION REASONABLY KNOWN TO US OUT OF AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869061 PANACEA BED 3500 MAH FNL NOA MEDICAL INDUSTRIES 1070014BEI 00817492011618

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Other