BEUDAMED
    FDA Adverse Event Other Summary report: N

    MINUET

    MDR report key: 2223431 · Received June 23, 2011

    Report

    Report Number
    3003984900-2011-00015
    Event Type
    Other
    Date Received
    June 23, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    ARJOHUNTLEIGH
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ARJOHUNTLEIGH SERVICE TECH VISITED THE SITE AND EVALUATED THE DEVICE WITH THE FOLLOWING RESULTS: ALL FUNCTIONS WORKING OK. CHECKED ALL POWER CABLES AND CONTROL CABLES FOR VISIBLE SIGNS OF DAMAGE, PAT TESTED BED, ALL CASINGS INSPECTED FOR DAMAGE; NO PROBLEMS FOUND. ALSO, THE BED HAD RECENTLY BEEN PAT TESTED AND APPROVED BY (B)(4) WHO ARE AN ELECTRICAL CONTRACTOR USED BY THE (B)(6) ON MAY 10TH, 2011. DUE TO NO ELECTRICAL FAULTS FOUND, IT IS OUR OPINION THAT THE SHOCK WAS CAUSED BY A BUILD UP OF STATIC ELECTRICAL ENERGY, AS IT WAS REPORTED THAT THE STAFF MEMBERS INVOLVED HAD ONLY JUST COMPLETED MAKING THE BED BY FOLDING SHEETS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT WHILE MAKING THE BED, THE 2 CARERS BOTH STATED THAT THEY RECEIVED AN ELECTRIC SHOCK FROM EITHER END OF THE BED. THE BED WAS ISOLATED AND REMOVED FROM USE. NO INJURIES REPORTED TO EITHER THE CAREGIVERS OR THE RESIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINUET COMMUNITY BED FNL ARJOHUNTLEIGH 161AA4A1A

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other