BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 2923201 · Received January 18, 2013

    Report

    Report Number
    3015876-2013-00057
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS UNABLE TO VERIFY THE REPORTED RESET AND POWER FAILURES. THE POWER SUPPLY ASSEMBLY WAS REPLACED DUE TO AN OPEN TECHNICAL SERVICE UPDATE TO THE DEVICE, AND THEN PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. THE REMOVED POWER SUPPLY ASSEMBLY WAS FURTHER EVALUATED IN THE FAILURE ANALYSIS CENTER. THE POWER PCB ASSEMBLY WITHIN THE SUPPLY ASSEMBLY WAS OBSERVED TO HAVE PROCESS RESIDUE ON FILTERS FL4 AND FL10 WHICH DOES CAUSE AN ISSUE WITH THE DC POWER. EVEN THOUGH THE PROCESS RESIDUE WAS OBSERVED, IT IS NOT CONCLUSIVE IF THIS WAS THE CAUSE OF THE REPORTED RESET AND POWER FAILURES.

    Additional Manufacturer Narrative · 1

    (B)(4). 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, A BIOMED, CONTACTED PHYSIO-CONTROL TO REPORT THAT HE WAS INVESTIGATING A REPORT OF THEIR DEVICE RESETTING WHEN ATTEMPTING TO POWER THE UNIT OFF. THE BIOMED STATED THAT WHEN HE PRESSED AND HELD DOWN THE ON BUTTON TO TURN THE UNIT OFF, THE DEVICE WOULD POWER DOWN MOMENTARILY BEFORE TURNING BACK ON AGAIN. THE ONLY WAY HE WAS ABLE TO POWER THE UNIT OFF WAS TO UNPLUGGED THE UNIT FROM IT'S AC POWER SOURCE AND REMOVE THE INTERNAL BATTERY. HE THEN REINSTALLED THE BATTERY AND PLUGGED THE UNIT BACK INTO THE AC POWER SOURCE, BUT THE UNIT WOULD NO LONGER POWER ON. THERE WERE WAS NOT A SERVICE INDICATOR PRESENT, NOR WERE THERE EVENT CODES IN THE DEVICE'S MEMORY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27398 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1