BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 3656163 · Received March 3, 2014

    Report

    Report Number
    3015876-2014-00200
    Event Type
    Malfunction
    Date Received
    March 3, 2014
    Date of Event
    February 6, 2014
    Report Date
    February 6, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: CATALOG NUMBER IN THE INITIAL MEDWATCH REPORT INDICATES: 3202359. CATALOG NUMBER OF THE INITIAL MEDWATCH REPORT SHOULD INDICATE: 3200731. NEW/ADDITIONAL INFORMATION FOR FOLLOW-UP MEDWATCH REPORT: PHYSIO-CONTROL ADVISED THE CUSTOMER THAT THE DEVICE WAS NOT FIELD SERVICEABLE AND NO LONGER UNDER WARRANTY. PHYSIO RECOMMENDED THAT THE CUSTOMER PURCHASE A REPLACEMENT DEVICE. THE CUSTOMER HAD ORIGINALLY TOLD PHYSIO-CONTROL THAT SHE WOULD RELEASE THE DEVICE TO PHYSIO FOR EVALUATION; HOWEVER, AFTER FOLLOWING UP WITH THE CUSTOMER IT DOES NOT APPEAR THAT THE DEVICE WILL BE RETURNED. 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 NO LONGER PROVIDED ANY AUDIO. AS A RESULT, THE VOICE PROMPTS INSTRUCTING END USERS ON HOW TO USE THE AED WERE NOT AVAILABLE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126842 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1