BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 4737861 · Received April 29, 2015

    Report

    Report Number
    3015876-2015-00480
    Event Type
    Malfunction
    Date Received
    April 29, 2015
    Date of Event
    December 3, 2014
    Report Date
    April 1, 2015
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER ADVISED PHYSIO-CONTROL THAT THEY ARE GOING TO RETIRE THE DEVICE FROM SERVICE AND HAS REQUESTED FOR THE DEVICE TO BE SCRAPPED. THE DEVICE HAS NOT BEEN RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED ISSUE. PHYSIO OBSERVED THAT THE INTERNAL HLC BATTERIES HAD BEEN DEPLETED AND APPEARED TO HAVE LEAKED ELECTROLYTE. THE HLC BATTERIES WILL NO LONGER RETAIN A CHARGE. PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED ISSUE. PHYSIO OBSERVED THAT THE INTERNAL HLC BATTERIES FROM THE ANALOG PCB ASSEMBLY HAD BEEN DEPLETED AND APPEARED TO HAVE LEAKED ELECTROLYTE. THE HLC BATTERIES WILL NO LONGER RETAIN A CHARGE.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED ISSUE. PHYSIO OBSERVED THAT THE INTERNAL HLC BATTERIES HAD BEEN DEPLETED AND APPEARED TO HAVE LEAKED ELECTROLYTE. THE HLC BATTERIES WILL NO LONGER RETAIN A CHARGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE WOULD NOT POWER ON. THERE WAS NO REPORT OF ANY PATIENT USE ASSOCIATED WITH THE REPORTED POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280602 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1