BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3023921 · Received March 27, 2013

    Report

    Report Number
    3015876-2013-00238
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO OBSERVED DAMAGE TO THE FLEX CABLE ASSEMBLY, WHICH CONNECTS THE USER INTERFACE PCB TO THE STACK. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED EVENT AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 1

    PHYSIO REPLACED THE FLEX CABLE ASSEMBLY, WHICH CONNECTS THE USER INTERFACE PCB TO THE STACK, AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED FLEX CABLE ASSEMBLY, WHICH CONNECTS THE USER INTERFACE PCB TO THE STACK, AT THE FAILURE ANALYSIS CENTER; HOWEVER NO DAMAGE WAS NOTED AND THE REPORTED FAILURE WAS NOT DUPLICATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS BEING USED TO MONITOR A PATIENT WHEN THE SERVICE INDICATION ILLUMINATED. THE DEVICE WAS THEN REMOVED FROM SERVICE AND ANOTHER DEVICE WAS USED TO MONITOR THE PATIENT. UPON EVALUATION BY THE BIOMEDICAL TECHNICIAN AT THE CUSTOMER SITE, THE DISPLAY WOULD COME ON; HOWEVER, THE DEVICE WOULD NOT ADVANCE PAST THE SELF TEST SCREEN. THE FAILURE OBSERVED BY THE BIOMEDICAL TECHNICIAN DID NOT OCCUR DURING PATIENT USE AND THE ILLUMINATION OF THE SERVICE INDICATION DURING PATIENT USE IS NOT RELATED TO THE OBSERVED BOOT-UP FAILURE. THERE WAS NO REPORT OF COMPROMISE TO PATIENT CARE OR AN ADVERSE EVENT ASSOCIATED WITH THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125810 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1