BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARIATRIC BED HEAD 9153641516

    MDR report key: 5451563 · Received February 22, 2016

    Report

    Report Number
    1031452-2016-00626
    Event Type
    Malfunction
    Date Received
    February 22, 2016
    Date of Event
    February 8, 2016
    Report Date
    February 8, 2016
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    OSI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THIS EVENT IS A DUPLICATE OF REPORT NUMBER 1031452-2016-00625. IT CONCERNS BAR5000IVC (HEAD SECTION) WITH SERIAL NUMBER (B)(4), WHICH IS FROM THE SAME BED (MODEL BAR600IVC) AS BAR5490IVC (FOOT SECTION) WITH SERIAL NUMBER (B)(4) REFERENCED IN 1031452-2016-00625.

    Description of Event or Problem · 1

    THE DEALER STATED THAT THEY RECEIVED A CORRESPONDENCE FROM THE VA STATING: EMERGENCY: PLEASE ASSESS/REPAIR CONTROLS ON HOSPITAL BED. PATIENT REPORTS THE WIRES BURNED UP, CAUSING THE FIRE DEPT. TO BE CALLED, AND THE BED WILL NOT WORK, IS STUCK WITH THE HEAD UP , PLACING THE PATIENT IN AN AWKWARD/DANGEROUS POSITION.

    Description of Event or Problem · 1

    THE DEALER STATED THAT THEY RECEIVED A CORRESPONDENCE FROM THE VA STATING: EMERGENCY: PLEASE ASSESS/REPAIR CONTROLS ON HOSPITAL BED. PATIENT REPORTS THE WIRES BURNED UP, CAUSING THE FIRE DEPT. TO BE CALLED, AND THE BED WILL NOT WORK, IS STUCK WITH THE HEAD UP , PLACING THE PATIENT IN AN AWKWARD/DANGEROUS POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109749 BARIATRIC BED HEAD 9153641516 BARIATRIC BED OSI INVACARE FLORIDA OPERATIONS BAR600IVC

    Patients

    Seq Age Sex Outcome Treatment
    1