BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3801067 · Received May 8, 2014

    Report

    Report Number
    3015876-2014-00517
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    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) THE BIOMEDICAL ENGINEER ADVISED THAT AFTER THOROUGHLY TESTING THE DEVICE HE WAS UNABLE TO DUPLICATE, OR VERIFY, THE REPORTED ISSUE. THERE WERE NO EVENT CODES IN THE DEVICE'S MEMORY, NOR WERE THERE ANY ELECTRONIC PATIENT RECORDS IN THE MEMORY THAT CORRESPONDED TO DATE AND TIME OF THE PATIENT EVENT. THE BIOMEDICAL ENGINEER ADVISED THAT IT WAS HIS OPINION THAT THE DEVICE MAY NOT HAVE BEEN PROPERLY ATTACHED TO THE PATIENT DURING THE EVENT, BUT HE COULD NOT BE CERTAIN WITH THE INFORMATION HE HAD BEEN PROVIDED BY THE DEVICE USER(S). AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS PLACED BACK INTO SERVICE FOR USE. PHYSIO-CONTROL HAS MADE NUMEROUS ATTEMPTS TO CONTACT THE CUSTOMER FOR ADDITIONAL INFORMATION ABOUT THE EVENT; HOWEVER, NO RESPONSE APPEARS TO BE FORTHCOMING. THE DEVICE HAS NOT BEEN RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER, A BIOMEDICAL ENGINEER, CONTACTED PHYSIO-CONTROL TO REPORT THAT THE DEVICE USER(S) STATED THAT THE UNIT WOULD NOT CHARGE WHEN PROMPTED DURING A RECENT PATIENT EVENT. AS A RESULT, THE DEVICE COULD NOT BE USED TO PROVIDE DEFIBRILLATION THERAPY. THE DEVICE USER(S) HAD ADVISED THE BIOMEDICAL ENGINEER THAT THEY HAD PRESSED THE CHARGE BUTTON ON THE DEVICE MULTIPLE TIMES BUT THAT THE UNIT WOULD NOT CHARGE. THE DEVICE USER(S) THEN OBTAINED A BACKUP DEVICE AND USED IT TO SUCCESSFULLY TREAT THE PATIENT. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277644 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1