BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARROLL BED

    MDR report key: 17532798 · Received August 12, 2023

    Report

    Report Number
    MW5139705
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    August 25, 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 ALLEGED THAT A CARROL BED, PART NUMBER E0092, SERIAL NUMBER (B)(6) HAD A MALFUNCTIONING CONTROL BOX. (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
    783779 CARROLL BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL INVACARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown