BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2973243 · Received February 21, 2013

    Report

    Report Number
    1525712-2013-01337
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    December 8, 2012
    Report Date
    February 21, 2013
    Manufacturer
    UNKNOWN
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED BY THE TERRITORY BUSINESS MANAGER THAT THE PATIENT WAS SITTING ON THE UNSPECIFIED INVACARE BED OPERATING THE HAND PENDANT, AND DURING THAT TIME THE HUSBAND ALLEGEDLY HEARD THE MOTOR GRINDING. HE ASKED HER TO STOP, AND GRABBED HER JUST BEFORE THE BED DROPLET THE HEAD SECTION, WHICH SLAMMED DOWN. THE EVENT ALLEGEDLY RESULTED IN BACK, NECK, AND SHOULDER INJURIES, AS WELL AS HER ARM BEING SEVERELY SWOLLEN AND THE BONE WAS PRESSING ON HER SKIN. MEDICAL INTERVENTION WAS SOUGHT, AND NO DETAILED INFORMATION WAS PROVIDED. SHOULD WE RECEIVE ADDITIONAL INFORMATION, THIS FILE WILL BE REVISED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    (B)(4) IT WAS REPORTED BY THE TERRITORY BUSINESS MANAGER THAT THE PATIENT WAS SITTING ON THE UNSPECIFIED INVACARE BED OPERATING THE HAND PENDANT, AND DURING THAT TIME THE HUSBAND ALLEGEDLY HEARD THE MOTOR GRINDING. HE ASKED HER TO STOP, AND GRABBED HER JUST BEFORE THE BED DROPLET THE HEAD SECTION, WHICH SLAMMED DOWN. THE EVENT ALLEGEDLY RESULTED IN INJURIES, AS WELL AS HER ARM BEING SEVERELY SWOLLEN, AND THE BONE PRESSING ON HER SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77475 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other