BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 8579809 · Received May 3, 2019

    Report

    Report Number
    0003015876-2019-00779
    Event Type
    Malfunction
    Date Received
    May 3, 2019
    Date of Event
    April 10, 2019
    Report Date
    June 15, 2020
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    UDI-DI
    00883873979358
    PMA / PMN Number
    K142430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PHYSIO-CONTROL ARCHIVED THE DEVICE AND PROVIDED THE CUSTOMER WITH A REPLACEMENT. PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED SYSTEM PCB ASSEMBLY AND DETERMINED A FAULTY SINGLE BOARD COMPUTER WAS THE ROOT CAUSE OF THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    PHYSIO-CONTROL FURTHER EVALUATED THE CUSTOMER¿S DEVICE AND DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS DUE TO THE SYSTEM PCB ASSEMBLY. DUE TO A PART OBSOLESCENCE, THE DEVICE CANNOT BE REPAIRED AT THIS TIME. THE CUSTOMER HAS RECEIVED A LOANER UNIT UNTIL A PERMANENT SOLUTION IS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD A SERVICE INDICATOR PRESENT. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL OBSERVED THAT IT WOULD FREEZE UP DURING THE INITIAL BOOT-UP PROCESS. AS A RESULT, DEFIBRILLATION WOULD NOT BE POSSIBLE IF IT WERE NECESSARY.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD A SERVICE INDICATOR PRESENT. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL OBSERVED THAT IT WOULD FREEZE UP DURING THE INITIAL BOOT-UP PROCESS. AS A RESULT, DEFIBRILLATION WOULD NOT BE POSSIBLE IF IT WERE NECESSARY.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED ISSUE. PHYSIO-CONTROL 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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD A SERVICE INDICATOR PRESENT. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL OBSERVED THAT IT WOULD FREEZE UP DURING THE INITIAL BOOT-UP PROCESS. AS A RESULT, DEFIBRILLATION WOULD NOT BE POSSIBLE IF IT WERE NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372612 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 15 00883873979358

    Patients

    Seq Age Sex Outcome Treatment
    1