BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW AIR LOSS BED

    MDR report key: 1883692 · Received September 27, 2010

    Report

    Report Number
    1883692
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    August 2, 2010
    Report Date
    September 27, 2010
    Manufacturer
    KCI
    Product Code
    INX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT FOUND BY NURSE TECH PINNED BETWEEN SIDE RAIL OF LOW AIR-LOSS BED AND THE BED. PATIENT'S HEAD AND TORSO WERE PINNED, LEGS WERE ON THE FLOOR. TECH IMMEDIATELY CALLED FOR HELP, FELLOW IMMEDIATELY NOTIFIED. NURSING AND MD ABLE TO GET SIDE RAIL DOWN AND LIFT PATIENT BACK INTO BED. PATIENT INITIALLY LETHARGIC, SHALLOW RESPIRATIONS, HEART RATE 110'S, HYPOTENSIVE. NO OBVIOUS DEFORMITIES NOTED. STAT X RAY'S AND EKG OBTAINED, STARTED PATIENT ON LEVOPHED, MD EXAMINED PATIENT, NO OBVIOUS INJURY FOUND OTHER THAN SMALL AMOUNT OF BLOOD IN BACK RIGHT CORNER OF THE MOUTH. PATIENT RETURNED TO BASELINE RESPONSIVENESS WITHIN 5 MINUTES OF BEING BACK IN BED. VITAL SIGNS ALSO STABILIZED WITHIN 10 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOW AIR LOSS BED BED - SPECIALTY INX KCI NOT KNOWN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR