BEUDAMED
    FDA Adverse Event Death Summary report: N

    RMA-ICCG BEDS

    MDR report key: 6930882 · Received October 9, 2017

    Report

    Report Number
    1531186-2017-00014
    Event Type
    Death
    Date Received
    October 9, 2017
    Date of Event
    September 2, 2017
    Report Date
    September 22, 2017
    Manufacturer
    INVACARE CORPORATION
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INFORMATION WAS SUPPLIED RELATING TO THE BED OR MATTRESS BUT THE RAILS WERE REPORTED TO BE AN INVACARE PRODUCT, NO SERIAL NUMBER OR MODEL WAS SUPPLIED. THE CPSC REPORT INDICATED THAT THE SUBMITTER REQUESTED THAT THEIR CONTACT INFORMATION NOT BE RELEASED TO THE MANUFACTURER, THEY DID NOT CONTACT THE MANUFACTURER THEMSELVES, NOR DO THEY PLAN ON DOING SO. INVACARE IS UNABLE TO VERIFY THAT THE BED RAILS ARE INDEED AN INVACARE PRODUCT OR TO OBTAIN ANY ADDITIONAL INFORMATION RELATING TO THIS EVENT, THE FACILITY, PROVIDER OR PRODUCT ORDERS. THE MODEL & MANUFACTURER OF THE BED AND MATTRESS REMAINS UNKNOWN. INVACARE IS UNABLE TO DETERMINE IF THERE WAS A MALFUNCTION THAT CAUSED OR CONTRIBUTED TO THE EVENT. INVACARE IS FILING THIS RECORD WITH THE U.S. FDA IN AN ABUNDANCE OF CAUTION BASED ON THE UNCONFIRMED ALLEGATION OF DEATH. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    A LETTER WAS RECEIVED BY INVACARE CORPORATION FROM THE US CONSUMER PRODUCT SAFETY COMMISSION (CPSC) STATING THAT A (B)(6) FEMALE PATIENT AT AN ASSISTED LIVING FACILITY BECAME WEDGED BETWEEN HER BED FRAME AND HER BED RAIL AND PASSED AWAY. THERE IS AN ALLEGATION THAT THE BED RAIL MAY NOT HAVE FIT PROPERLY. THE BED RAILS ARE REPORTED TO BE MANUFACTURED BY INVACARE. CPSC RECORD # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708956 RMA-ICCG BEDS BED, AC-POWERED ADJUSTABLE HOSPITAL FNL INVACARE CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Death