BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOW AIR LOSS THERAPY SYSTEM

    MDR report key: 26390 · Received September 8, 1995

    Report

    Report Number
    26390
    Event Type
    Injury
    Date Received
    September 8, 1995
    Date of Event
    August 24, 1995
    Manufacturer
    INTEGRATED THERAPY PRODUCTS, INC.
    Product Code
    INX
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    RESIDENT'S LIGHT WAS FLASHING AND WHEN CNA ENTERED ROOM THE RESIDENT HAS HAD SLID OUT OF BED ON CHUX OFF TOP OF AIR MATTRESS. LEFT LEG LYING ON TOP OF THE RAILING ON BOTTOM OF BEDSIDE TABLE, LEFT HAND STILL HANGING ON TO 1/2 SIDE RAIL ON (L) SIDE OF BED. FOLLOW-UP X-RAYS SHOWED BROKEN (R) LEG.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: . SERVICE PROVIDED BY: INVALID DATA. SERVICE RECORDS AVAILABLE.IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: TELEMETRY FAILURE. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: USE OF ALL SIMILAR DEVICES STOPPED PERMANENTLY. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOW AIR LOSS THERAPY SYSTEM KIN AIR BED INX INTEGRATED THERAPY PRODUCTS, INC. MRS 1500

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention