BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR PLUS DEFIBRILLATOR

    MDR report key: 1934123 · Received December 3, 2010

    Report

    Report Number
    3015876-2010-01319
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K011144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A FOLLOW-UP CALL WAS MADE TO THE CUSTOMER; IN WHICH THEY INDICATED THAT THE DEVICE WILL BE REMOVED FROM SERVICE AND REPLACED WITH A NEW ONE. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE DEVICE HAD ALL THREE ICONS ILLUMINATED (SERVICE, ATTENTION AND CHARGE-PAK). THE DEVICE DID POWER ON; HOWEVER, THIS FAILURE IS INDICATIVE OF A DEVICE THAT WILL NOT REMAIN POWERED ON LONG ENOUGH FOR APPROPRIATE DEFIBRILLATION TO BE DELIVERED. THERE WAS NO REPORT OF PT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK CR PLUS DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC CRPLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA