BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3521914 · Received December 16, 2013

    Report

    Report Number
    3015876-2013-01400
    Event Type
    Malfunction
    Date Received
    December 16, 2013
    Date of Event
    November 18, 2013
    Report Date
    November 18, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER) IN THE INITIAL MEDWATCH REPORT INDICATES: 3202459. (CATALOG NUMBER) IN THE INITIAL MEDWATCH REPORT SHOULD INDICATE: 3202488.

    Additional Manufacturer Narrative · 1

    (B)(4). AT THE CUSTOMER'S REQUEST, PHYSIO-CONTROL ASSISTED THE CUSTOMER WITH PURCHASING A REPLACEMENT THERAPY CONNECTOR ASSEMBLY. AFTER MULTIPLE ATTEMPTS, PHYSIO-CONTROL HAS BEEN UNABLE TO CONTACT THE CUSTOMER FOR ADDITIONAL INFORMATION ABOUT THE REPORTED ISSUE. THE DEVICE HAS NOT BEEN RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT PROVIDE DEFIBRILLATION ENERGY DURING TESTING. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656136 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1