BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALP 501

    MDR report key: 2739074 · Received July 25, 2012

    Report

    Report Number
    2023637-2012-00001
    Event Type
    Injury
    Date Received
    July 25, 2012
    Date of Event
    April 23, 2012
    Report Date
    June 29, 2012
    Manufacturer
    CURRIE MEDICAL SPECIALTIES
    Product Code
    JOW
    PMA / PMN Number
    K955853
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER REPORTED THAT THE INJURY OBTAINED BY THE PT, WAS DUE TO THE PT TRIPPING OVER "VENODYNE BOOTS". WE HAVE BEEN UNABLE TO CONFIRM THAT THE PT WAS IN FACT WEARING "VENODYNE" BRAND BOOTS AS OPPOSED TO ALP GARMENT(S) THROUGH CORRESPONDENCE WITH THE REPORTING PARTY. WE HAVE INFORMED THE REPORTING PARTY, THAT OUR ALP 501 PUMP IS NOT TO BE USED WITH ANOTHER MFR'S DEVICE. VENODYNE BRAND COMPRESSION GARMENTS ARE NOT MANUFACTURED BY CURRIE MEDICAL SPECIALTIES INC., AND ARE NOT CLEARED FOR USE WITH OUR ALP 501 PUMP. THE INTENDED USE OF THE ALP 501 PUMP IS WITH THE ALP SERIES GARMENTS CLEARED UNDER 510(K) K955853 ONLY. DURING OUR EVAL OF THE CLAIM, IT WAS FOUND THAT THIS DEATH OCCURRED OUTSIDE OF THE BED. THE USER HAS BEEN NOTIFIED THAT THE OPERATIONS MANUAL FOR THE ALP 501 PUMP SPECIFICALLY STATES "IF THE PT IS AMBULATORY, TURN THE PUMP OFF AN DISCONNECT THE TUBING FROM THE GARMENTS. THE PT MAY AMBULATE WITH ONLY THE CALF AND THIGH GARMENTS IN PLACE. ONCE THE PT RETURNS TO THE CHAIR OR BED, CONNECT THE TUBING TO THE GARMENTS AND TURN THE PUMP ON." IF THE PT WAS AMBULATORY AS DESCRIBED ON FORM 3500A, THE HEALTH PROFESSIONAL SHOULD HAVE DISCONNECTED THE PT PRIOR TO ALLOWING THE PT TO LEAVE THE BED. THIS WOULD HAVE PREVENTED THE INJURY IF THE DIRECTIONS WITHIN THE OPERATOR'S MANUAL WERE FOLLOWED CORRECTLY. CURRIE MEDICAL SPECIALTIES HAS REQUESTED MORE INFO THE REPORTING PARTY ON THE FOLLOWING DATES WITH NO SUCCESS: 7/11/12-EMAIL, 7/16/12-EMAIL,7/12/12-PHONE, 7/24/12-PHONE 7/25/12-EMAIL.

    Description of Event or Problem · 1

    PT WAS DISCOVERED BY HEALTH TECH TO BE ON FLOOR AT APPROX 11:20 PM. PT FOUND TO BE FACEDOWN WITH MODERATE POOL OF BLOOD AROUND HEAD AREA. WHEN TURNED OVER FOUND TO BE PULSELESS WITH NO SOUNDS. CODE BLUE INITIATED. PT STATUS WAS DNR/DNI. TIME OF DEATH PRONOUNCED AT 11:27PM. UPON CONDUCING ROOT CAUSE ANALYSIS AND AUTOPSY, IT WAS DETERMINED THAT THE PT WAS TRIPPED UP BY THE VENODYNE BOOTS THAT HE WAS TETHERED TO, CAUSING HIM TO FALL AND HIT HIS HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALP 501 ALTERNATING LEG PRESSURE PUMP JOW CURRIE MEDICAL SPECIALTIES ALP 501

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death