BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE PM KIT VAMP PLUS

    MDR report key: 2151964 · Received July 7, 2011

    Report

    Report Number
    2015691-2011-15838
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 14, 2011
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    PMA / PMN Number
    K925638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE DPT-VAMP KIT WAS RETURNED FOR ANALYSIS WITH PRESSURE AND IV TUBING ATTACHED. PRIMING SOLUTION WAS VISIBLE INSIDE OF THE KIT. THE DPT ZEROED AND SENSED PRESSURE ACCURATELY . PRESSURE READINGS WERE ALSO STABLE DURING TESTING. PRESSURE DID NOT SHOW ANY DRIFT DURING TESTING FOR 8 HOURS. ELECTRICAL TESTING SHOWED THAT BOTH INPUT AND OUTPUT IMPEDANCE MET SPECIFICATIONS. NO VISIBLE DEFECT WAS FOUND ON THE SUPERCOMAL CABLE CONNECTOR. PRESSURE TESTING WAS PERFORMED USING A GE MONITOR AND PRESSURE GAUGE. ELECTRICAL AND CONTINUITY TESTING WAS PERFORMED USING A DIGITAL MULTIMETER. VISUAL EXAMINATION WAS PERFORMED UNDER 10X MAGNIFICATION. THE COMPLAINT OF A FALSE PRESSURE READING WAS NOT CONFIRMED AND NO EVIDENCE OF A MANUFACTURING DEFECT WAS FOUND DURING THE ANALYSIS. IT COULD NOT BE DETERMINED IF ANY CLINICAL FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT. NO ACTIONS WILL BE TAKEN AT THIS TIME. A DEVICE HISTORY RECORD REVIEW WAS COMPLETE AND DOCUMENTED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE GAVE A FALSE BLOOD PRESSURE READING OF 190/140. THE WAVEFORM WAS NORMAL AND THE NURSE WEANED OFF THE "PRESSURES" (BELIEVED TO MEAN VASOPRESSORS). THE RN INFORMED THE MD AND RECEIVED AN ORDER TO GO BY ARTERIAL LINE. THE CUFF READING WAS 70/40'S. THE CUSTOMER DID NOT FEEL COMFORTABLE WITH THE ARTERIAL LINE READING. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE PM KIT VAMP PLUS DISPOSABLE PRESSURE TRANSDUCER DXO EDWARDS LIFESCIENCES DR PXVP2284 59026450

    Patients

    Seq Age Sex Outcome Treatment
    1