BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE BARIATRIC PLUS W/ AIR BED

    MDR report key: 3830216 · Received May 12, 2014

    Report

    Report Number
    1824206-2014-01465
    Event Type
    Malfunction
    Date Received
    May 12, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    PMA / PMN Number
    K122473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECH INVESTIGATED AND WAS UNSURE OF WHAT CAUSED THE FAILURE AND DID NOT FIND THAT THE BRAKES WERE DEFECTIVE. THE BED WAS SWAPPED FOR A KNOWN WORKING BED PER THE FAMILY'S REQUEST. THE BRAKE CASTERS ARE ON ORDER TO BE REPLACED AND THE BED WAS TAKEN BACK TO THE HILL-ROM SERVICE CENTER. NO FURTHER INFO IS AVAILABLE RELEVANT INFO IS IDENTIFIED FOLLOWING COMPLETION OF THE REPAIR, THE ADD'L RELEVANT INFO WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THAT THE LEFT FOOT BRAKE CASTER WAS NOT HOLDING WHILE IN BRAKE MODE WHEN THE PT ENTERED THE BED. THE BED WAS LOCATED IN 613 AT THE FACILITY. THERE WAS NO PT/USER INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283349 TOTALCARE BARIATRIC PLUS W/ AIR BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1840

    Patients

    Seq Age Sex Outcome Treatment
    1