BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 5518182 · Received March 22, 2016

    Report

    Report Number
    3015876-2016-00325
    Event Type
    Malfunction
    Date Received
    March 22, 2016
    Date of Event
    February 20, 2016
    Report Date
    March 22, 2016
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K142430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER EVALUATED THE DEVICE AND DUPLICATED THE REPORTED ISSUE. IT WAS DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS DUE TO A LOOSE KEP NUT ON THE BATTERY WIRE HARNESS. THIS KEP NUT BEING LOOSE CAUSED THE DEVICE TO POWER OFF. A REPLACEMENT DEVICE HAD BEEN PROVIDED TO THE CUSTOMER UNDER WARRANTY.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND DOWNLOADED THE ELECTRONIC PATIENT RECORD. FROM THE DOWNLOADED ELECTRONIC PATIENT RECORD IT WAS OBSERVED THAT THE DEVICE HAD INDEED POWERED OFF. THE REPORTED ISSUE COULD HOWEVER NOT BE REPRODUCED. PHYSIO CONTINUES TO INVESTIGATE THE REPORTED ISSUE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE POWERED OFF SEVERAL TIMES WHEN THEY USED THE DEVICE TO MONITOR A PATIENT. THERE WAS PATIENT USE ASSOCIATED WITH THE REPORTED EVENT HOWEVER, THERE WAS NO ADVERSE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173889 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR