BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK® 15 DEFIBRILLATOR/MONITOR

    MDR report key: 8203755 · Received December 28, 2018

    Report

    Report Number
    0003015876-2018-02221
    Event Type
    Malfunction
    Date Received
    December 28, 2018
    Date of Event
    December 2, 2018
    Report Date
    February 18, 2019
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    UDI-DI
    00883873911648
    PMA / PMN Number
    K142430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PHYSIO-CONTROL FURTHER EVALUATED THE CUSTOMER'S DEVICE AND DETERMINED THAT THE CAUSE FOR THE REPORTED ISSUE WAS DUE TO A LOOSE KEP-NUT (LOCK NUT WHICH WAS ATTACHING THE BATTERY WIRE HARNESS TO THE BATTERY PIN ASSEMBLY) FOR BATTERY 2. PHYSIO REPLACED ALL FOUR KEP NUTS AND THE BATTERY PINS AS A PRECAUTION. AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING, THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE POWERED ITSELF OFF DURING PATIENT USE. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED. THERE WAS NO REPORT OF ADVERSE EFFECTS TO THE PATIENT DUE TO THE REPORTED ISSUE. PHYSIO-CONTROL HAS ATTEMPTED TO CONTACT THE CUSTOMER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ON THE PATIENT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL PERFORMED AN INITIAL EVALUATION OF THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED. 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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE POWERED ITSELF OFF DURING PATIENT USE. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED. THERE WAS NO REPORT OF ADVERSE EFFECTS TO THE PATIENT DUE TO THE REPORTED ISSUE. PHYSIO-CONTROL HAS ATTEMPTED TO CONTACT THE CUSTOMER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ON THE PATIENT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042209 LIFEPAK® 15 DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 15 00883873911648

    Patients

    Seq Age Sex Outcome Treatment
    1