BEUDAMED
    FDA Adverse Event Other Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2061080 · Received April 7, 2011

    Report

    Report Number
    1525712-2011-00154
    Event Type
    Other
    Date Received
    April 7, 2011
    Date of Event
    March 10, 2011
    Report Date
    April 7, 2011
    Manufacturer
    MERITS HEALTH PRODUCTS CO., LTD.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USER ALLEGES HE JIGGLED THE CORD THAT GOES INTO THE CONTROL BOX AND OBSERVED SPARKS. USER HAS HAD THE BED SERVICED IN THE PAST AND CLAIMS THE SERVICE PERSONNEL WAS NOT ABLE TO CHECK THE ELECTRICAL ISSUE. THE DEALER WAS CONTACTED AND HAS ADVISED HE HAS ORDERED THE PARTS TO REPAIR THE USER'S BED. FILING SOLELY ON THE USER'S ALLEGATION OF SPARKS OBSERVED. PRODUCT HAS NOT BEEN RETURNED FOR EVAL AT THIS TIME, SO IT IS UNK IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE OR ABUSE, OR LACK OF MAINTENANCE MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. MALFUNCTION IS NOT CONFIRMED.

    Description of Event or Problem · 1

    THE CONSUMER'S SON ALLEGES THERE WERE SPARKS COMING OUT OF THE CONTROL BOX WHEN HE JIGGLED THE CORD THAT GOES INTO THE CONTROL BOX. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL MERITS HEALTH PRODUCTS CO., LTD. 3010 PROBASICIS BARRIA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR