BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE PRESSURE TRANSDUCER

    MDR report key: 2062641 · Received April 19, 2011

    Report

    Report Number
    2015691-2011-15255
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 21, 2011
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED ONE SINGLE DPT KIT WITH ATTACHED INFUSION SET AND PRESSURE TUBING. PRIMING SOLUTION WAS VISIBLE INSIDE OF THE IV TUBING. NO PRIMING SOLUTION WAS VISIBLE INSIDE OF THE DPT FLUID PATH AND PRESSURE TUBING. REPORTED DEFECT OF "SENSOR PAD OF DPT WAS NOT ADHERED WELL, AND MOVED DURING PRIMING" WAS NOT CONFIRMED. THE SURFACE OF THE SENSOR GEL APPEARED DAMAGED AND PART OF THE GEL WAS MISSING. THE GEL DID NOT MOVE DURING PRIMING FROM 2 FEET HEIGHT PER IFU RECOMMENDATION. FURTHERMORE, THE GEL DID NOT MOVE AT 350 MMHG PRESSURE (SIMULATED 300MMHG FROM PRESSURIZED IV BAG AND 50MHG FROM 2FT HEAD HEIGHT) FOR 5 MINUTES. TESTING WAS PERFORMED WITH LAB PRESSURE GAUGE AND STOPWATCH. VISUAL EXAMINATIONS WERE PERFORMED UNDER MICROSCOPE AT 10X MAGNIFICATION. THOUGH WE HAVE CONFIRMED THE PRODUCT WAS DAMAGED, THERE WAS NO EVIDENCE OF A MANUFACTURING NONCONFORMANCE FOUND DURING THE EVALUATION. THE DEVICE SERVICE HISTORY RECORD REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "SENSOR PAD OF DPT SEEMED LIKE IT WAS NOT ADHERED WELL, AND IT MOVED DURING PRIMING. IT IS UNKNOWN WHETHER THE PAD MOVED FROM THE BEGINNING OR NOT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1