BEUDAMED
    FDA Adverse Event Death Summary report: N

    WRIST RESTRAINTS

    MDR report key: 822743 · Received February 23, 2007

    Report

    Report Number
    822743
    Event Type
    Death
    Date Received
    February 23, 2007
    Date of Event
    February 7, 2007
    Report Date
    February 7, 2007
    Manufacturer
    J.T. POSEY
    Product Code
    FMQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED WITH SMALL BOWEL OBSTRUCTION (SBO) IN 2007. HE UNDERWENT SURGERY FOR RELEASE OF THE SBO THE NEXT DAY. POSTOPERATIVELY , HE EXPERIENCED RESPIRATORY INSUFFICIENCY, CARDIAC ARRHYTHMIA AND RENAL INSUFFICIENCY. HIS CODE STATUS WAS: ALL BUT CPR, NO DEFIBRILLATION/NO INTUBATION PER THE INSTRUCTIONS OF HIS LEGAL POWER OF ATTORNEY. HIS PROGNOSIS WAS CONSIDERED POOR. THREE DAYS LATER AT 0010 HOURS, HE ARRESTED. EXTRAORDINARY MEASURES WERE WITHHELD IN COMPLIANCE WITH THE CODE STATUS AND HE WAS PRONOUNCED. BECAUSE HE WAS REACHING FOR AND PULLING AT TUBES, DRAINS, AND IV'S, SOFT WRIST RESTRAINTS WERE INITIATED THREE DAYS EARLIER AT 2330 HRS. THE WRIST RESTRAINTS WERE STILL IN PLACE AT THE TIME OF HIS DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WRIST RESTRAINTS WRIST RESTRAINTS FMQ J.T. POSEY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death