BEUDAMED
    FDA Adverse Event Other Summary report: N

    POWERED PT ROTATION BED

    MDR report key: 2083109 · Received April 29, 2011

    Report

    Report Number
    1525712-2011-00171
    Event Type
    Other
    Date Received
    April 29, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 28, 2011
    Manufacturer
    KAP MEDICAL
    Product Code
    IKZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USER ALLEGES THEY SAW A PUFF OF SMOKE AND SMELLED A BURNING SMELL FROM THE UNIT. DEVICE HAS BEEN IN SERVICE FOR TWO MONTHS AND IT IS UNK IF THE COMPLAINT IS A RESULT OF DROPPING DEVICE, MECHANICAL WEAR OR A MALFUNCTION. THE UNIT WAS UNPLUGGED AND TAKEN OUT OF SERVICE. FILLING SOLELY ON THE USER'S ALLEGATION OF SMOKE, MALFUNCTION IS NOT CONFIRMED. MANUFACTURER IS ATTEMPTING TO OBTAIN PRODUCT FOR INSPECTION.

    Description of Event or Problem · 1

    THE CONSUMER'S AIDE ALLEGEDLY SAW A PUFF OF SMOKE AND SMELLED A BURNING SMELL AFTER THE UNIT HAD BEEN RUNNING ALL NIGHT. THE AIDE UNPLUGGED THE UNIT FROM THE WALL. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED PT ROTATION BED 890.5225 IKZ KAP MEDICAL MA85

    Patients

    Seq Age Sex Outcome Treatment
    1