BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 7956812 · Received October 11, 2018

    Report

    Report Number
    0003015876-2018-01692
    Event Type
    Malfunction
    Date Received
    October 11, 2018
    Date of Event
    September 26, 2018
    Report Date
    December 3, 2018
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    PMA / PMN Number
    K142430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE CUSTOMER¿S DEVICE AND WAS ABLE TO DUPLICATE THE REPORTED ISSUE. PHYSIO THEN REPLACED THE SYSTEM BOARD ASSEMBLY TO RESOLVE THE REPORTED ISSUE. AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED SYSTEM PCB ASSEMBLY AND DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS THE SINGLE BOARD COMPUTER (SBC) LOCATED ON THE ASSEMBLY. THE SBC WAS INOPERATIVE, WHICH PREVENTED THE DEVICE FROM COMPLETING THE BOOT-UP PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT WHEN ATTEMPTING TO POWER ON THEIR DEVICE, IT WILL NOT COMPLETE THE BOOT-UP PROCESS. AS A RESULT, DEFIBRILLATION MAY NOT BE POSSIBLE, IF IT WERE NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT WHEN ATTEMPTING TO POWER ON THEIR DEVICE, IT WILL NOT COMPLETE THE BOOT-UP PROCESS. AS A RESULT, DEFIBRILLATION MAY NOT BE POSSIBLE, IF IT WERE NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798367 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 15

    Patients

    Seq Age Sex Outcome Treatment
    1