BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPAK 20

    MDR report key: 2915490 · Received January 9, 2013

    Report

    Report Number
    2915490
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 9, 2013
    Manufacturer
    PHYSIO-CONTROL INC.
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MACHINE IN PACER MODE AND SET FOR RATE OF 60. PATIENT HAD BURN WOUNDS ON CHEST AND DIFFICULTY WITH PADS STICKING TO TISSUE. PATIENT RATE BECAME ASYSTOLE AND MACHINE DID NOT FIRE. REVIEW OF MACHINE BY CLINICAL ENGINERING DID NOT IDENTIFY ANY MECHANICAL PROBLEMS. NURSE REPORTED MACHINE DID FIRE AFTER THIS MISSED FIRE, PADS WERE MORE SECURE INTO PATIENT AT THAT TIME. NURSE ALSO REPORTED DIFFICULTY WITH PADS STICKING WITH EQUIPMENT IN CATH LAB. PATIENT ASYSTOLE 20-30 SECS. NURSE AT BEDSIDE AND COMPRESSIONS STARTED. PATIENT TO CATH LAB FOR EMERGENT TEMPORARY PACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10501 LIFEPAK 20 AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL INC. LIFEPAK 20 *

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R CARDIAC DRUGS