BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3953632 · Received July 23, 2014

    Report

    Report Number
    3015876-2014-00842
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    AS A PRECAUTION, PHYSIO-CONTROL REPLACED BOTH THE SYSTEM CONTROLLER (SC) AND USER INTERFACE (UI) PCB ASSEMBLIES AND AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EXAMINED THE UI PCB ASSEMBLY AND OBSERVED THAT AN INTEGRATED CIRCUIT (IC) CHIP, DESIGNATOR U8, WOULD CAUSE AN INTERMITTENT BLANK SCREEN; HOWEVER, THE UNIT WAS OTHERWISE OPERATIONAL AND WOULD STILL DELIVER DEFIBRILLATION THERAPY WHEN PROMPTED. THERE WAS NO EVIDENCE OF A DEVICE LOCK UP OBSERVED. THE REMOVED SC PCB ASSEMBLY WAS AN ANCILLARY PART AND THERE WAS NO FAILURE OF THE ASSEMBLY. THE CAUSE OF THE ORIGINAL ISSUE, DEVICE LOCK UP, COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE CUSTOMER¿S DEVICE BUT WAS UNABLE TO VERIFY OR DUPLICATE THE REPORTED ISSUE. AFTER PHYSIO-CONTROL OBSERVES PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING, THE DEVICE WILL BE RETURNED TO THE CUSTOMER FOR USE.THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT WHEN MONITORING A PATIENT THE DEVICE DISPLAYED A WHITE SCREEN. THIS IS AN INDICATION THAT THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430118 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1