BEUDAMED
    FDA Adverse Event Death Summary report: N

    KIN AIR/TC

    MDR report key: 35055 · Received May 9, 1996

    Report

    Report Number
    35055
    Event Type
    Death
    Date Received
    May 9, 1996
    Date of Event
    May 1, 1996
    Report Date
    May 8, 1996
    Manufacturer
    KINETEIC CONCEPTS
    Product Code
    INX
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    THE PT WAS IN THE CO BED IN A SUPINE POSITION. SHE HAD 5 POINT SOFT RESTRAINTS (WRISTS, WAIST AND ANKLES). SHE ALSO HAD HARD BOARD RESTRAINT ON EACH ELBOW. THE BED SIDE RAILS WERE UP. AGAINST THE INSIDE OF THE BED SIDE RAILS WAS A HARD CUSHIONED PLASTIC GUARD (PROVIDED BY THE BED MFR) WHICH RAN THE ENTIRE LENGTH AND HEIGHT OF THE SIDE RAIL (HEAD TO FOOT), AND BETWEEN THE PLASTIC GUARD AND THE AIR MATTRESS WAS AN ADD'L 2 INCH THICK AND WRAPPED IN BLANKETS PADDING (DEVICED BY RPTR), WHICH ALSO RAN THE ENTIRE LENGTH AND HEIGHT OF BOTH SIDE RAILS (HEAD TO FOOT). BOTH THE PADDING AND THE GUARD WERE USED TO DECREASE THE SPACE BETWEEN THE MATTRESS AND THE SIDE RAIL. THE PT WAS ABLE TO KNOCK BOTH THE PADDING AND THE PADDED PLASTIC GUARD TOWARD THE LOWER HALF OF THE BED. SHE THEN MANEUVERED HER BODY IN SUCH A WAY THAT SHE PINNED HER THROAT BETWEEN THE MATTESS AND POINT #3 (SEE DRAWING OF BED). THE DESIGN OF THE CO BED AND SIDE BOARD CONTRIBUTED IN FAILING TO PREVENT THE PT FROM GETTING HER NECK BETWEEN THE AIR MATTRESS AND UNDER THE LOWER EDGE OF THE SIDERAIL.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. DATE LAST SERVICED: 01-APR-96. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO 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, MECHANICAL TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE, DESIGN - INADEQUATE. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT, DEVICE FAILURE RELATED TO PATIENT CONDITION, DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE, DEVICE USE CONTINUED WITH RESTRICTIONS/LIMITATIONS, OTHER. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIN AIR/TC KIN AIR/TC INX KINETEIC CONCEPTS 4001 3B

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Death