BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3961764 · Received July 28, 2014

    Report

    Report Number
    3015876-2014-00860
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 28, 2014
    Report Date
    June 30, 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

    (B)(4). PHYSIO-CONTROL EXAMINED THE CUSTOMER'S DEVICE BUT WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. PHYSIO DID OBSERVE THAT THE USER INTERFACE (UI) TO STACK FLEX CABLE ASSEMBLY HAD A SMALL TEAR NEAR THE CABLE-MOUNTED PLUG CONNECTOR, DESIGNATOR P21. AS A PRECAUTION, THE UI TO STACK FLEX CABLE ASSEMBLY WAS THEN REPLACED AND AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE.

    Additional Manufacturer Narrative · 1

    AFTER RECEIVING THEIR DEVICE BACK FROM PHYSIO-CONTROL, THE CUSTOMER IMMEDIATELY CONTACTED PHYSIO TO REPORT THAT THEIR DEVICE WAS BOOTING UP WITH A WHITE DISPLAY WHICH IS INDICATIVE OF A DEVICE LOCK UP CONDITION. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE; THE CUSTOMER, A BIOMEDICAL ENGINEER, WAS INSPECTING THE DEVICE AFTER RECEIVING IT BACK FROM PHYSIO. THE DEVICE WAS RETURNED TO PHYSIO FOR EVALUATION. PHYSIO EXAMINED THE CUSTOMER'S DEVICE BUT WAS UNABLE TO DUPLICATE OR VERIFY THE REPORTED ISSUE. AS A PRECAUTION, PHYSIO REPLACED BOTH THE SYSTEM CONTROLLER (SC) AND USER INTERFACE (UI) PCB ASSEMBLIES. AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT DURING A RECENT PATIENT EVENT THE DISPLAY ON THEIR DEVICE TURNED WHITE. A WHITE DISPLAY IS INDICATIVE OF A POTENTIAL DEVICE LOCK-UP. THE CUSTOMER OBTAINED A BACKUP DEVICE THAT WAS READILY AVAILABLE AND USED IT TO PROVIDE CARE TO THE PATIENT. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. NO FURTHER INFORMATION ABOUT THE PATIENT OR THE EVENT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439332 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1