BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL

    MDR report key: 2872291 · Received December 5, 2012

    Report

    Report Number
    2872291
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    December 2, 2012
    Report Date
    December 5, 2012
    Manufacturer
    ZOLL MFG
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING TREATMENT OF A FEMALE PT THE E SERIES MONITOR WAS APPLIED TO THE PATIENT. THE PARAMEDIC CREW ATTEMPTED A 12 LEAD EKG, AT WHICH TIME MONITOR PROVIDED ERROR MESSAGE "V6 LEAD OFF." THE CREW CHANGED THE ELECTRODE AND ATTEMPTED AGAIN, MONITOR STILL READ "V6 LEAD OFF", CREW THEN EXCHANGED THE MONITORING CABLES WITH BRAND NEW SET AND ATTEMPTED 3RD 12 LEAD TRACING. MONITOR STILL HAD ERROR MESSAGE OF "V6 LEAD OFF". CREW CONTINUED TO TREAT PATIENT AND TOOK PATIENT TO CLOSEST HOSPITAL WITH UNKNOWN OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOLL E SERIES MONITOR MKJ ZOLL MFG E SERIES

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR