BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 9864947 · Received March 23, 2020

    Report

    Report Number
    0003015876-2020-00397
    Event Type
    Malfunction
    Date Received
    March 23, 2020
    Date of Event
    February 11, 2020
    Report Date
    March 23, 2020
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    PMA / PMN Number
    K142430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PHYSIO CONTROL SERVICE REPRESENTATIVE EVALUATED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED ISSUE IN A REVIEW OF THE ELECTRONIC RECORDS. DURING AN INTERNAL INSPECTION IT WAS OBSERVED THAT THERE WAS A LOOSE KEP NUT IN BATTERY WELL 2, WHICH CAUSED A HIGH VOLTAGE DROP WHEN DRAWING A HIGH CURRENT. AFTER TIGHTENING THE LOOSE KEP NUT AND PERFORMING SOME UNRELATED REPAIRS, PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS SUBSEQUENTLY RETURNED TO THE CUSTOMER. PHYSIO-CONTROL CONTACTED THE CUSTOMER TO REQUEST ADDITIONAL INFORMATION ON THE PATIENT. THE CUSTOMER PROVIDED PHYSIO-CONTROL WITH ALL THE AVAILABLE PATIENT INFORMATION.

    Description of Event or Problem · 1

    THE THIRD-PARTY SERVICE AGENT CONTACTED PHYSIO CONTROL TO REPORT THAT THEIR CUSTOMER'S DEVICE HAD UNEXPECTEDLY LOST POWER WHILE MONITORING A PATIENT. THERE WERE NO REPORTS OF ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332816 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 15

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR