BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 5540383 · Received March 31, 2016

    Report

    Report Number
    3015876-2016-00380
    Event Type
    Malfunction
    Date Received
    March 31, 2016
    Date of Event
    March 10, 2016
    Report Date
    March 31, 2016
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K142430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER, A BIOMEDICAL ENGINEER, ADVISED THAT HE WAS ABLE TO DUPLICATE THE REPORTED ISSUE. THE BIOMEDICAL ENGINEER THEN REQUESTED THAT THE DEVICE BE EVALUATED BY PHYSIO-CONTROL. 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 EVALUATED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED ISSUE. PHYSIO DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS THAT THE KEPS NUT IN BOTH BATTERY WELL #1 AND BATTERY WELL #2 WERE LOOSE. PHYSIO THEN TIGHTENED BOTH KEPS NUTS TO SPECIFICATION AND COMPLETED OTHER, UNRELATED, REPAIRS. AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    THE CUSTOMER, A BIOMEDICAL ENGINEER, CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD POWERED OFF BY ITSELF DURING A PATIENT EVENT. THE CUSTOMER ADVISED THAT MEDICAL PERSONNEL HAD JUST FINISHED WITH THE PATIENT WHEN ONE OF THEM PRESSED THE "EVENT" BUTTON, FOLLOWED BY THE "CODE SUMMARY" BUTTON, AND THE DEVICE POWERED OFF BY ITSELF. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195883 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1