BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3083577 · Received April 29, 2013

    Report

    Report Number
    3015876-2013-00343
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CLINICAL REVIEW OF THE FILE WAS PERFORMED; HOWEVER THERE WAS INSUFFICIENT INFORMATION TO DETERMINE IF THE DEVICE USE CONTRIBUTED TO THE OUTCOME OF THE PATIENT. PHYSIO-CONTROL EXAMINED THE CUSTOMER'S DEVICE BUT WAS UNABLE TO VERIFY, NOR DUPLICATE, THE REPORTED FAILURE. PHYSIO OBSERVED THAT THE UNIT WAS ABLE TO SUCCESSFULLY CHARGE AND DISCHARGE DEFIBRILLATION ENERGY WITHOUT DISCREPANCY. AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WILL BE RETURNED TO THE CUSTOMER FOR USE. AFTER MULTIPLE ATTEMPTS, PHYSIO-CONTROL HAS BEEN UNABLE TO CONTACT THE CUSTOMER FOR ADDITIONAL INFORMATION REGARDING THE REPORTED ISSUE. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4): 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DELIVERED ONE DEFIBRILLATION SHOCK AND ANOTHER FOUR MINUTES LATER; HOWEVER THERE WERE MULTIPLE FAILURES TO DELIVER DEFIBRILLATION SHOCKS BETWEEN THE TWO. THE PATIENT WAS NOT RESUSCITATED. THERE WAS NO ADVERSE EVENT REPORTED AS THE RESULT OF THE DEVICE USE. NO FURTHER INFORMATION REGARDING THE PATIENT OR THE EVENT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185210 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1