BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 16112164 · Received January 6, 2023

    Report

    Report Number
    2438477-2022-00131
    Event Type
    Injury
    Date Received
    January 6, 2023
    Date of Event
    October 28, 2022
    Report Date
    January 6, 2023
    Manufacturer
    EEZCARE MEDICAL CORP
    Product Code
    FNM
    UDI-DI
    00822383111605
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A PRESSURE PREVENTION MATTRESS VIA MEDWATCH REPORT. THE INITIAL REPORTER STATED THAT "HIS PATIENT SUFFERED BRUISING ON HER HEAD FROM FALLING OUT OF THE MATTRESS," REPORTEDLY BECAUSE THE "PUMP WAS NOT WORKING, CAUSING THE MATTRESS TO DEFLATE," "WHICH THEN CAUSED THE PATIENT TO FALL ON THE FLOOR." THE PATIENT WAS REPORTEDLY ADMITTED TO THE HOSPITAL AND HAS BEEN RECEIVING THERAPY POST-HOSPITALIZATION. DRIVE OBTAINED THE UNIT FOR EVALUATION, DURING WHICH IT WAS DETERMINED THAT THE PUMP OPERATES AS INTENDED AND FILLS BLADDER TO FULL HEIGHT. DURING EVALUATION, DRIVE NOTED THAT THE UNIT'S EMERGENCY CORD, USED TO DEFLATE THE UNIT IMMEDIATELY IF CPR IS NECESSARY, WAS DISCONNECTED WHEN RECEIVED. IF THE EMERGENCY CORD WAS DISCONNECTED DURING USE, IT WOULD RESULT IN THE COMPLETE DEFLATION OF THE BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238777 DRIVE MATTRESS FNM EEZCARE MEDICAL CORP 14030XP 00822383111605

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization