BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARROLL BED

    MDR report key: 17533847 · Received August 12, 2023

    Report

    Report Number
    MW5140750
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    September 12, 2014
    Manufacturer
    INVACARE CORPORATION
    Product Code
    FNL
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    STRYKER MEDICAL WAS NOTIFIED OF A POTENTIALLY REPORTABLE COMPLAINT INVOLVING A PRODUCT FOR WHICH STRYKER IS NOT THE ORIGINAL EQUIPMENT MANUFACTURER OF THE REPORTED DEVICE. THE CUSTOMER REPORTED THAT A CARROL BED, SERIAL NUMBER (B)(6), HAD A MALFUNCTIONING FOWLER ACTUATOR. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074205 CARROLL BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL INVACARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown