BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEART START XL

    MDR report key: 6057228 · Received October 26, 2016

    Report

    Report Number
    1218950-2016-06684
    Event Type
    Injury
    Date Received
    October 26, 2016
    Report Date
    September 29, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. UDI #: N/A.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SPOKE WITH NUMEROUS PHILIPS TECHNICAL SUPPORT REPRESENTATIVES (TSR), WHO ADVISED THAT THE SYSTEM BE RETURNED WITH THE PADDLES FOR FURTHER EVALUATION. THE CUSTOMER DECLINED TO SEND THE DEVICE AND PADDLES AS THERE WERE NO LOANERS AVAILABLE AT THIS TIME. THE CUSTOMER BIOMED CONDUCTED SEVERAL TESTS ON THE DEVICE AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE CUSTOMER WAS PROVIDED THE PART NUMBER FOR THE REQUIRED PADDLES AS REQUESTED. THE DEVICE REMAINS AT THE CUSTOMER SITE. BASED OFF THE PROVIDED EMAIL INFORMATION WHICH CAN BE VIEWED IN THE "FSE NOTES AND INSPECTION DATA" SECTION OF THIS PR. THE CUSTOMER DECLINED TO SEND THE DEVICE AND PADDLES TO PHILIPS FOR A FULL EVALUATION DESPITE THE NUMEROUS ATTEMPTS MADE BY PHILIPS REPRESENTATIVE. THE CUSTOMER STATED IN THE EMAIL THAT THE ERROR LOGS WERE REVIEWED AND NO ERRORS WERE OBSERVED. THE CUSTOMER ALREADY PLACED AN ORDER FOR THE INTERNAL PADDLE SET. THE DEVICE REMAINS AT THE CUSTOMER SITE. IT WAS CONCLUDED THAT THE DEVICE'S INTERNAL PADDLE SET MALFUNCTIONED AND CONTRIBUTED TO THE REPORTED PROBLEM, BUT THERE IS NO INDICATION OF ANY ADVERSE IMPACT. THE CUSTOMER DECLINED PHILIPS' REQUEST TO HAVE THE DEVICE RETURNED FOR EVALUATION BECAUSE NO LOANER WAS AVAILABLE AT THE CURRENT TIME. THE CUSTOMER TESTED THE DEVICE IN HOUSE AND WAS UNABLE TO DUPLICATE THE FAILURE AFTER SEVERAL TESTS. THE CUSTOMER ORDERED A NEW INTERNAL PADDLE SET. THE DEVICE REMAINS AT THE CUSTOMER SITE. THERE IS NO INDICATION OF A SYSTEMIC PROBLEM; NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE'S INTERNAL PADDLES CHARGED, BUT FAILED TO DISCHARGE DURING AN OPEN HEART SURGERY CASE. IT WAS REPORTED THAT THE DEVICE WAS IN CLINICAL USE DURING OPEN HEART SURGERY WHEN THE FAILURE WAS OBSERVED. AS OF 18-OCT-2016, THE CUSTOMER DID NOT REPORT ANY ADVERSE PATIENT IMPACT. DETAILS WERE NOT PROVIDED THAT THERE WAS A DELAY IN THERAPY, OR WHAT ACTIONS WERE TAKEN AFTER THE OBSERVED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710506 HEART START XL DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1