BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

    MDR report key: 1823103 · Received September 1, 2010

    Report

    Report Number
    2015691-2010-13990
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    July 29, 2010
    Report Date
    August 4, 2010
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    PMA / PMN Number
    K925638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE CUSTOMER REPORTED DEFECT WAS NOT CONFIRMED. THE TRIPLE KIT WAS RETURNED AND ALL DISPOSABLE PRESSURE TRANSDUCERS ZEROED AND SENSED PRESSURE. DURING 8 HOURS TESTING, THE PRESSURE DID NOT SHOW ANY DRIFT AND WAS WITHIN SPECIFICATIONS. ELECTRICAL TESTING SHOWED THAT BOTH INPUT AND OUTPUT IMPEDANCE WERE WITHIN SPECIFICATIONS. ZERO-OFFSET ALSO MET SPECIFICATION PER DIRECTIONS FOR USE. NO VISIBLE DEFECTS WERE FOUND AT THE SUPERCOMAL CABLE CONNECTORS.

    Description of Event or Problem · 1

    REPORTEDLY, THE PRESSURE BASE LINE IS UNSTABLE. AFTER ZEROING, THE PRESSURE SIGNAL INCREASED CONTINUOUSLY SO, IT WAS RE-ZEROED, WHICH DID NOT CORRECT THE ISSUE. AFTER THE DPT WAS CHANGED OUT FOR A NEW ONE, THEN THE SIGNAL WAS STABLE. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD HAD APPARENT CONDUCTOR FRACTURE. THE LEAD WAS NOTED TO HAVE BEEN UNIPOLARIZED. THE LEAD WAS REMOVED AND REPLACED. DURING THE IMPLANT ATTEMPT OF THE NEW LEAD, IT WAS REPORTED THAT THE STYLET BECAME KINKED IN THE LEAD AND THERE WAS DIFFICULTY REMOVING THE STYLET FROM THE LEAD. THE LEAD WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUWAVE DISPOSABLE PRESSURE TRANSDUCER DISPOSABLE PRESSURE TRANSDUCER DXO EDWARDS LIFESCIENCES DR PX3X3 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1