BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE, VAMP PLUS

    MDR report key: 23659314 · Received November 26, 2025

    Report

    Report Number
    2015691-2025-09607
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    November 5, 2025
    Report Date
    February 20, 2026
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    UDI-DI
    07460691950177
    PMA / PMN Number
    K142749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODES: KRA. ADDITIONAL PREMARKET SUBMISSION: K181684, K896819. THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW.

    Additional Manufacturer Narrative · 0

    A PRODUCT EVALUATION WAS COMPLETED ON THE RETURNED TRANSDUCER. THE REPORTED EVENT OF "INACCURATE PRESSURE READINGS" WAS UNABLE TO BE CONFIRMED. DPT ZEROED AND SENSED PRESSURE ACCURATELY ON PRESSURE MONITOR. A PRESSURE OF 150 MMHG WAS APPLIED. INITIAL PRESSURE READING WAS 150MMHG AND FINAL PRESSURE READING WAS 150 MMHG. PRESSURE DID NOT SHOW ANY DRIFT DURING OUTPUT DRIFT TESTING AND MET SPECIFICATION. SPEC WAS +/-1 MMHG/8 HOUR. ELECTRICAL TESTING SHOWED THAT BOTH INPUT IMPEDANCE (2,240 OHMS) AND OUTPUT IMPEDANCE (300 OHMS) WERE WITHIN SPECIFICATIONS. SPECIFICATIONS WERE 1,200 OHMS TO 3,400 OHMS FOR INPUT IMPEDANCE AND 285 OHMS TO 315 OHMS FOR OUTPUT IMPEDANCE. ZERO-OFFSET (1 MMHG) ALSO MET SPECIFICATION. ZERO-OFFSET SPECIFICAION IS +/-25 MMHG. NO VISIBLE DAMAGE WAS OBSERVED FROM THE KIT. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. AS NO DEFECT WAS FOUND, A PRODUCT NON-CONFORMANCE OR DEVICE FAILURE COULD NOT BE CONFIRMED AND NO ROOT CAUSE COULD BE DETERMINED. IN ADDITION, A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED. AS PART OF THE MANUFACTURING PROCESS 100% OF THE UNITS GO THROUGH A FLOW, LEAK, VOLTAGE, AND ELECTRICAL TEST. THE INSTRUCTIONS FOR USE (IFU) STATES "PRESSURE READINGS CAN CHANGE QUICKLY AND DRAMATICALLY BECAUSE OF LOSS OF PROPER CALIBRATION, LOOSE CONNECTION, OR AIR IN THE SYSTEM. AND "ABNORMAL PRESSURE READINGS SHOULD CORRELATE WITH THE PATIENT'S CLINICAL MANIFESTATIONS." INSTRUCTIONS INCLUDE TESTING DYNAMIC RESPONSE AND NOTES THAT POOR DYNAMIC RESPONSE CAN BE CAUSED BY AIR BUBBLES, CLOTTING, EXCESSIVE LENGTHS OF TUBING, EXCESSIVELY COMPLIANT PRESSURE TUBING, SMALL BORE TUBING, LOOSE CONNECTIONS, OR LEAKS. WARNING: MOISTURE WITHIN THE CONNECTOR MAY RESULT IN THE DEVICE MALFUNCTIONING OR IN INACCURATE PRESSURE READINGS. IF THIS OCCURS, REPLACE WET PART OR PARTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING USE, A PRESSURE MONITORING DEVICE HAD INACCURATE PRESSURE READINGS COMPARED TO AN ARM CUFF. A-LINE READ 102/54 AND THE ARM CUFF READ 197/44. IT WAS STATED THAT THE A-LINE HAD GOOD SQUARE WAVEFORM AND ALL APPROPRIATE TROUBLESHOOTING WERE COMPLETED. NO ALLEGATIONS OF PATIENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309733 TRUWAVE, VAMP PLUS TRANSDUCER, PRESSURE, CATHETER TIP DXO EDWARDS LIFESCIENCES DR PXVP2284 07460691950177

    Patients

    Seq Age Sex Outcome Treatment
    1