BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3063823 · Received March 29, 2013

    Report

    Report Number
    3003793491-2013-00398
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 5, 2013
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT YET REC'D THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS REC'D AND WHEN IT IS EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE SHIFT CHECK, THE DEVICE DISPLAYED USER ADVISORY 16 (TIMEOUT MOVING TO TAKE-UP POSITION) AND USER ADVISORY 17 (MAX MOTOR ON TIME EXCEEDED DURING ACTIVE OPERATION). THE PLATFORM SOUNDS ABNORMAL WHEN WINDING THE LIFEBAND. THE LIFEBAND DID NOT COMPLETELY WIND WHEN PRESSING "START" AFTER THE DEVICE WAS POWERED ON. NO OTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129634 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other