BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 4355481 · Received December 23, 2014

    Report

    Report Number
    3015876-2014-01545
    Event Type
    Malfunction
    Date Received
    December 23, 2014
    Date of Event
    October 30, 2014
    Report Date
    November 26, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K142430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. 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

    PHYSIO-CONTROL FURTHER EVALUATED THE DEVICE AND DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO AN INTEGRATED CIRCUIT (IC) CHIP, DESIGNATOR U15 ON THE SYSTEM PCB ASSEMBLY, HAVING BAD SOLDER JOINTS. THIS INTEGRATED CIRCUIT (IC) CHIP, DESIGNATOR U15 ON THE SYSTEM PCB ASSEMBLY, HAVING BAD SOLDER JOINTS, CAUSED THE DEVICE CONTROLS TO BE UNRESPONSIVE AFTER BOOT-UP. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER UNDER WARRANTY.

    Additional Manufacturer Narrative · 1

    PMA/510(K)NUMBER, OF THE INITIAL MEDWATCH REPORT INDICATES: K103567. PMA/510(K)NUMBER, OF THE INITIAL MEDWATCH REPORT SHOULD INDICATE: K142430.

    Description of Event or Problem · 1

    THE PHYSIO-CONTROL SERVICE REPRESENTATIVE REPORTED THAT THE ECG AND THERAPY FUNCTIONS ON HIS DEVICE WERE NOT WORKING AND THAT THE DEVICE'S SPEED DIAL WAS INOPERATIVE. THE DEVICE WAS REPORTED TO POWER ON AND OFF AUTOMATICALLY AND NO DATA COULD BE DOWNLOADED FROM THE DEVICE THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847003 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1