BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 6212081 · Received December 29, 2016

    Report

    Report Number
    3015876-2016-01633
    Event Type
    Malfunction
    Date Received
    December 29, 2016
    Date of Event
    December 1, 2016
    Report Date
    December 29, 2016
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K130454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE BUT COULD NOT REPRODUCE THE REPORTED ISSUE. 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.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER EVALUATED THE DEVICE BUT COULD NOT OBSERVE ANY DISCREPANCIES IN SHOCK DELIVERY DURING TESTING. PHYSIO PERFORMED SOME UNRELATED REPAIRS. AFTER HAVING CONFIRMED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING, THE DEVICE WAS RETURNED TO THE CUSTOMER. A CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DID NOT DELIVER A DEFIBRILLATION SHOCK DURING USE ON A PATIENT. A 200 JOULES DEFIBRILLATION SHOCK HAD BEEN ADMINISTERED TO THE PATIENT, BUT THE HOSPITAL CREW WANTED TO DELIVER A 360 JOULES SHOCK, THE DEVICE CHARGED DEFIBRILLATION ENERGY, BUT DID NOT DELIVER THE SHOCK. CPR WAS INITIATED AND THE DEVICE THEN REPORTEDLY SHOCKED WITHOUT THE SHOCK BUTTON BEING PUSHED. THERE WAS NO ADVERSE OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861917 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR