BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3060053 · Received April 16, 2013

    Report

    Report Number
    3015876-2013-00300
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    February 24, 2013
    Report Date
    March 22, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MEDWATCH REPORT INDICATES: A THIRD-PARTY SERVICE AGENT EVALUATED THE DEVICE BUT COULD NOT VERIFY THE REPORTED FAILURE. THE THIRD-PARTY SERVICE AGENT OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. IT WAS OBSERVED THAT THE SPRING CONTACT BETWEEN THE PEDIATRIC AND ADULT HARD PADDLE PLATE WAS BROKEN. DUE TO THIS BAD CONTACT THE DEVICE WOULD POSSIBLY NOT PROVIDE DEFIBRILLATION THERAPY. THE BROKEN PADDLE WAS DISCARDED AND IS NOT AVAILABLE FOR FURTHER EVALUATION. THE CUSTOMER HAS ORDERED A NEW HARD PADDLES ASSEMBLY. THE INITIAL MEDWATCH REPORT SHOULD INDICATE: A THIRD-PARTY SERVICE AGENT EVALUATED THE DEVICE BUT COULD NOT VERIFY THE REPORTED FAILURE. THE THIRD-PARTY SERVICE AGENT OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE HARD PADDLES ASSEMBLY WAS DISCARDED AND IS NOT AVAILABLE FOR FURTHER EVALUATION. THE CUSTOMER REPORTED THAT THE SPRING CONTACT BETWEEN THE PEDIATRIC AND ADULT HARD PADDLE PLATE WAS BROKEN. DUE TO THIS BAD CONTACT THE DEVICE WOULD POSSIBLY NOT PROVIDE DEFIBRILLATION THERAPY. THE CUSTOMER HAS ORDERED A NEW HARD PADDLES ASSEMBLY. A CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4): A THIRD-PARTY SERVICE AGENT EVALUATED THE DEVICE BUT COULD NOT VERIFY THE REPORTED FAILURE. THE THIRD-PARTY SERVICE AGENT OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. IT WAS OBSERVED THAT THE SPRING CONTACT BETWEEN THE PEDIATRIC AND ADULT HARD PADDLE PLATE WAS BROKEN. DUE TO THIS BAD CONTACT THE DEVICE WOULD POSSIBLY NOT PROVIDE DEFIBRILLATION THERAPY. THE BROKEN PADDLE WAS DISCARDED AND IS NOT AVAILABLE FOR FURTHER EVALUATION. THE CUSTOMER HAS ORDERED A NEW HARD PADDLES ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO A PHYSIO-CONTROL SERVICE REPRESENTATIVE THAT THE CUSTOMER'S DEVICE, WHILE IN USE ON A PATIENT, DIDN'T SHOCK IN MANUAL MODE AND THAT THE BUTTON TO CHARGE THE DEFIBRILLATION PADDLES MIGHT NOT FUNCTION. THE PHYSIO-CONTROL SERVICE REPRESENTATIVE FOUND OUT IN A PHONE CONVERSATION WITH THE CUSTOMER THAT THE ISSUE WAS RELATED TO A BROKEN HARD PADDLE (THE SPRING BETWEEN THE ADULT HARD PADDLE PLATE AND THE CHILD PADDLE PLATE WAS BROKEN). THEREFORE DEFIBRILLATION THERAPY COULD POSSIBLY NOT BE PROVIDED WHEN NEEDED. THERE WAS NO ADVERSE OUTCOME FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162677 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1