BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEELBO WRAP-AROUND VEST W/ STRAP SLIT

    MDR report key: 5068 · Received June 17, 1993

    Report

    Report Number
    5068
    Event Type
    Death
    Date Received
    June 17, 1993
    Date of Event
    May 20, 1993
    Report Date
    May 27, 1993
    Manufacturer
    HEELBO, INC.
    Product Code
    FMQ
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    RESIDENT WAS RETURNED TO BED BY HIS LPN AT 1:00 PM FOR A NAP WITHA PATIENT SAFETY DEVICE APPLIED. HE WAS OBSERVED AS RECENTLY AS 1:20 PM BY NURSING STAFF AND WAS OBSERVEXD TO BE RESTING COMFORTABLY. AT 1:30 PM, A STAFF MEMBER FOUND THE RESIDENT IN ACUTE DISTRESS. HE WAS ON THE SIDE OF THE BED, CYANOTIC WITH NO PULSE OR RESPIRATIONS. STAFF IMMEDIATELY RESPONDED WITH RESUSCITATIVE EFFORTS AND CALLED THE RESUE SQUAD. HE WAS TRANSPORTED TO A LOCAL HOSPITAL WHERE HE DIED THE SAME DAY. THESE PATIENT SAFETY DEVICES, MANUFACTURED BY POSEY, SKILCARE AND HEELBO, ARE IN USE AT THIS FACILITYDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: USER EDUCATION PROVIDED. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEELBO WRAP-AROUND VEST W/ STRAP SLIT CRISS-CROSS PROTECTIVE VEST FMQ HEELBO, INC. 9425

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death