BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 6451022 · Received March 31, 2017

    Report

    Report Number
    3015876-2017-00386
    Event Type
    Malfunction
    Date Received
    March 31, 2017
    Date of Event
    February 28, 2017
    Report Date
    March 31, 2017
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K142430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MEDWATCH REPORT INDICATES: PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS UNABLE TO DUPLICATE THE REPORTED ISSUE.  PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. PHYSIO-CONTROL PERFORMED A CLINICAL REVIEW OF THE REPORTED EVENT AND DETERMINED THAT THE DEVICE USE DID NOT CONTRIBUTE TO THE PATIENT'S DEATH.   THE INITIAL MEDWATCH REPORT SHOULD HAVE INDICATED: PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS UNABLE TO DUPLICATE THE REPORTED ISSUE.  PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.  AFTER A REVIEW OF THE ELECTRONIC DEVICE KEYLOG, IT WAS VERIFIED THAT THE REPORTED ISSUE OCCURRED AND ADDITIONALLY, IT WAS DETERMINED THAT THE LIKELY CAUSE WAS AN INTERMITTENT CONNECTION TO THE BATTERY IN BATTERY BAY 2.   PHYSIO-CONTROL PERFORMED A CLINICAL REVIEW OF THE REPORTED EVENT AND DETERMINED THAT THE DEVICE USE DID NOT CONTRIBUTE TO THE PATIENT'S DEATH. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INITIAL MEDWATCH REPORT INDICATED: CATALOG NUMBER - 11171-000037. THE INITIAL MEDWATCH REPORT SHOULD HAVE INDICATED: CATALOG NUMBER - 99577-001957. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS UNABLE TO DUPLICATE THE REPORTED ISSUE.  PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. PHYSIO-CONTROL PERFORMED A CLINICAL REVIEW OF THE REPORTED EVENT AND DETERMINED THAT THE DEVICE USE DID NOT CONTRIBUTE TO THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE LOST POWER SEVERAL TIMES DURING A PATIENT EVENT.  THE CUSTOMER INDICATED THAT THEY WERE ABLE TO UTILIZE A BACKUP DEVICE, BUT NO FURTHER INFORMATION ON THE EVENT HAS BEEN PROVIDED.  THE PATIENT DID NOT SURVIVE THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230864 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR