BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUMEN IQ CUFF ADULT

    MDR report key: 19667731 · Received July 3, 2024

    Report

    Report Number
    2015691-2024-05096
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    June 20, 2024
    Report Date
    August 23, 2024
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXN
    UDI-DI
    00690103219067
    PMA / PMN Number
    K230919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED AFTER THE CASE. WITHOUT RETURN OF THE UNIT IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. HOWEVER, AN INVESTIGATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE LOT NUMBER. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETE. PER THE INSTRUCTIONS FOR USE IT STATES, DO NOT APPLY FINGER CUFF OR CUFFS ON A HAND OR A FINGER WHEN A SECOND BLOOD PRESSURE MEASUREMENT DEVICE IS ACTIVELY MONITORING ON THE SAME ARM OR HAND OR FINGER 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 DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. A CLINICAL EVALUATION WAS ALSO COMPLETED ON A PHOTO TAKEN DURING THE EVENT. ONE MONITOR PHOTO WAS REVIEWED. PRESENCE OF HEMODYNAMIC VALUES AND TWO DIFFERENT BLOOD PRESSURE 159/101 (116) AND 113/73 (91) WERE CONFIRMED. BUT, WITHOUT FULL CLINICAL PICTURE AND CLINICAL CONTEXT, UNABLE TO DETERMINE WHICH VALUE IS TRUE. THE ADULT CUFF (AIQCA) HAS BEEN TESTED AND SHOWN TO BE ACCURATE ON FINGERS WITH CIRCUMFERENCES RANGING FROM 43 TO 71 MM. IT ALSO HAS BEEN TESTED AND SHOWN TO BE ACCURATE WHEN COMPARED TO BLOOD PRESSURE MEASUREMENTS FROM AN ARTERIAL LINE. HOWEVER, AN IN DEPTH INVESTIGATION TO CONFIRM DEVICE FUNCTIONALITY OR POTENTIAL MANUFACTURING ISSUE COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED. AN IMAGE WAS PROVIDED FOR EVALUATION BUT THE REPORTED EVENT WAS NOT ABLE TO BE CONFIRMED. REVIEWS OF THE DHR, LOT HISTORY AND MANUFACTURING MITIGATIONS REVEALED NO INDICATION OF A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE REPORTED COMPLAINT. AS SUCH, BASED ON AVAILABLE INFORMATION, A DEFINITE ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME. A PRODUCT RISK ASSESSMENT WAS INITIATED TO ADDRESS THE INCREASE OF OCCURRENCE. CURRENT RISK MITIGATION(S)/CONTROL MEASURE(S) INCLUDE 100% VISUAL INSPECTION, 100% ELECTRICAL TEST AND QA SAMPLING INSPECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A AIQCA BLOOD PRESSURE READING WAS DIFFERENT COMPARED TO A SPACELABS NIBP ARM CUFF THROUGHOUT A PROCEDURE. STAFF MOVED CUFF TO DIFFERENT FINGERS AND SWITCHED CUFF ON THE SAME SIDE OF THE BRACHIAL CUFF BUT CONTINUED TO HAVE ISSUES. CUFF WAS CONNECTED TO A HEMOSPHERE. NO PATIENT INFORMATION PROVIDED OTHER THAN PATIENT HAS AFIB. THERE WERE NO PATIENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508224 ACUMEN IQ CUFF ADULT SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DXN EDWARDS LIFESCIENCES DR AIQCA 65654021 00690103219067

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown