BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW VPS RHYTHM MONITOR BUNDLE

    MDR report key: 11133254 · Received January 7, 2021

    Report

    Report Number
    3011137372-2021-00002
    Event Type
    Malfunction
    Date Received
    January 7, 2021
    Date of Event
    December 16, 2020
    Report Date
    December 16, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    LJS
    PMA / PMN Number
    K160925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) A VPS RHYTHM MONITOR WITH ACCESSORIES WAS RETURNED. A VISUAL EXAMINATION REVEALED ALL RETURNED ITEMS WERE IN ACCEPTABLE CONDITION. DURING FUNCTIONAL TESTING, THE RETURNED MONITOR PASSED ALL STEPS, INDICATING THE UNIT WAS FUNCTIONING AS INTENDED. THE INTERNAL ECG SIGNAL WAS NORMAL DURING ALL TESTING. NO PROBLEM WAS FOUND WITH THE FUNCTIONALITY OF THE INTERNAL ECG SIGNAL ON THE RETURNED MONITOR. A REVIEW OF STORED CASES REVEALED A FEW HAD MULTIPLE SNAPSHOTS WHILE MOST DID NOT HAVE MULTIPLE SNAPSHOTS AS INTENDED FOR CHECKLIST VERIFICATION. ALSO, SOME CASES HAD A GOOD ELEVATED P WAVE WHILE OTHER CASES DID NOT. THE COMPLAINANT DID NOT IDENTIFY ANY SPECIFIC CASE TO SUPPORT THE COMPLAINT. THE RHYTHM MONITOR DOES NOT STORE THE ENTIRE CASE PROCEDURE, THEREFORE THERE IS NOTHING TO BE REVIEWED OR ANALYZED. THE REPORTED ISSUE "THEY WERE HAVING CONSISTENT ISSUES WITH GETTING A PEAKED P-WAVE" WAS SOMEWHAT CONFIRMED IN THE STORED CASES BUT COULD NOT BE REPRODUCED. THE REPORTED ISSUE "ONCE THEY GET A PEAKED P-WAVE THAT IT IS NOT CORRELATING WITH CXR AND THE PICC IS NOT IN THE CAJ" COULD NOT BE CONFIRMED OR REPRODUCED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE VPS RHYTHM UNIT AND DID NOT REVEAL ANY MANUFACTURING RELATED ISSUES. THE PROBABLE CAUSE OF THIS ISSUE CANNOT BE DETERMINED SINCE THE REPORTED EVENT CANNOT BE REPRODUCED AND NO PROBLEM WAS FOUND WITH THE FUNCTIONALITY OF THE INTERNAL ECG SIGNAL ON THE RETURNED MONITOR. TELEFLEX WILL CONTINUE TO MONITOR AND TREND REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    CUSTOMER REPORTS ISSUES GETTING A PEAKED P-WAVE AND ONCE THEY GET A PEAKED P-WAVE THAT IT IS NOT CORRELATING WITH CHEST X-RAY AND THE PICC IS NOT IN THE CAJ (CAVOATRIAL JUNCTION). NO REPORT OF A PATIENT INJURY OR COMPLICATION. PATIENT CONDITION REPORTED AS FINE.

    Additional Manufacturer Narrative · 1

    QN# (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTS ISSUES GETTING A PEAKED P-WAVE AND ONCE THEY GET A PEAKED P-WAVE THAT IT IS NOT CORRELATING WITH CHEST X-RAY AND THE PICC IS NOT IN THE CAJ (CAVOATRIAL JUNCTION). NO REPORT OF A PATIENT INJURY OR COMPLICATION. PATIENT CONDITION REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29976 ARROW VPS RHYTHM MONITOR BUNDLE CATHETER INTRAVASCULAR THERAPE LJS ARROW INTERNATIONAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1