BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-RISER

    MDR report key: 2136365 · Received April 10, 2007

    Report

    Report Number
    1931947-2007-00003
    Event Type
    Malfunction
    Date Received
    April 10, 2007
    Date of Event
    March 19, 2007
    Report Date
    April 9, 2007
    Manufacturer
    NOA MEDICAL INDUSTRIES, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED ON THE SIDE OF CAUTION. THE ACTUATORS THAT RAISE AND LOWER THE BED ARE SPECIFICALLY DESIGNED SO THAT THE BED CANNOT FREE FALL UNLESS THE ACTUATORS ARE PERMANENTLY AND PHYSICALLY BROKEN. THESE BEDS HAVE TWO ELEVATION ACTUATORS - BOTH ACTUATORS WOULD HAVE TO FAIL SIMULTANEOUSLY TO ALLOW THE BED TO FREE FALL. THESE RETURNED BEDS WERE FULLY FUNCTIONAL AND IN EXCELLENT CONDITION AFTER THE ALLEGED FREE FALL. IN SPITE OF THESE FACTS THE RESIDENT CLAIMS THAT BOTH BEDS DID INDEED FREE FALL TO THE GROUND. TESTING PERFORMED: BOTH BEDS WERE RETURNED TO NOA FOR EVAL. VISUAL INSPECTION FOUND ONLY SUPERFICIAL SIGNS OF USE. SERIAL NUMBER (B)(4) HAD ONE REPLACEMENT ACTUATOR. THE OPERATION OF BOTH BEDS WAS SMOOTH AND QUIET. NO UNUSUAL MOVEMENT OR NOISE WAS OBSERVED WHEN RAISING OR LOWERING THE BED. STATIC LOADS OF 350 LBS, 450 LBS, 550 LBS, AND 650 LBS (150 LBS. ABOVE THE BEDS 500 SL SAFE WORKING LOAD) WERE APPLIED WITH A DWELL TIME OF 5 MINUTES FOR EACH LOAD. THE LOADS WERE PLACED ON THE SEAT AND KNEE DECK TO APPROXIMATE WHERE THE RESIDENT WOULD ENTER THE BED. ONLY A NORMAL AND EXPECTED 1/8 INCH FLEXING OF THE FRAME WAS OBSERVED. BOTH BEDS WERE CYCLED TEN TIMES COMPLETELY UP AND COMPLETELY DOWN WITH 300 LBS ON THE SEAT DECK. NO UNUSUAL MOVEMENT OR SOUND WAS OBSERVED. CONCLUSION: BOTH BEDS ARE IN EXCELLENT CONDITION AND WORKING PROPERLY. THERE IS NO SCIENTIFIC EXPLANATION FOR HOW THESE BEDS COULD HAVE FREE FALLEN.

    Description of Event or Problem · 1

    BED, SERIAL NUMBER (B)(4), ALLEGEDLY FREE FELL TO THE GROUND WHEN THE RESIDENT WAS GETTING INTO BED - RETURNING FROM THE BATHROOM. THE MFR WAS CONTACTED AND THE BED WAS TAKEN OUT OF USE AND REPLACED WITH THE SAME MODEL BED. THE BED WAS OPERATED AFTER THE ALLEGED INCIDENT AND WAS FUNCTIONING PROPERLY. THE RESIDENT EXPERIENCED ONLY MINOR DISCOMFORT. LESS THAN 24 HOURS LATER THE REPLACEMENT BED, SERIAL NUMBER (B)(4), ALSO ALLEGEDLY FREE FELL TO THE GROUND WHEN THE SAME RESIDENT WAS GETTING OUT OF THE BED AND REACHING FOR THE WALKER. THE BED WAS NOT OPERATED AFTER THE ALLEGED FREE FALL. THE RESIDENT EXPERIENCED MORE DISCOMFORT THIS SECOND TIME. THE MFR WAS CONTACTED AND THE BED WAS TAKEN OUT OF SVC. THE RESIDENT WAS MOVED INTO A RENTAL BED THAT WAS A DIFFERENT MODEL AND MFR. THE RESIDENT REC'D X-RAYS. THERE WERE NO VISIBLE SIGNS OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-RISER FNL NOA MEDICAL INDUSTRIES, INC. 1040010BLK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR