BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECARECOMPANION

    MDR report key: 6760954 · Received August 2, 2017

    Report

    Report Number
    1125873-2017-00006
    Event Type
    Injury
    Date Received
    August 2, 2017
    Report Date
    July 18, 2017
    Manufacturer
    VISICU, INC - DUP
    Product Code
    DXN
    PMA / PMN Number
    K043217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PHILIPS H2H Q&R HAS COMPLETED THE INVESTIGATION FOR THE REPORT OF A BP CUFF CAUSING BRUISING AFTER USE. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION SO TESTING ON THIS SPECIFIC DEVICE WAS NOT POSSIBLE. HOWEVER, THE VENDOR (A&D) PREVIOUSLY INVESTIGATED BP CUFFS OF THE SAME PRODUCT FAMILY THAT CAUSED BRUISING AFTER USE. A&D CONDUCTED A MAXIMUM INFLATION LEVEL TEST SINCE OVER-INFLATION IS THE MOST COMMON CAUSE OF ARM BRUISING DURING/AFTER USE. THE RETURNED DEVICES STOPPED INFLATION AT 299 MMHG AND MET THE SAFETY DESIGN REQUIREMENT OF 300 MMHG. THE INFLATION LEVEL OF THE BP MEASUREMENT DEPENDS ON THE PATIENT¿S HYPERTENSIVE CONDITION. THE BP CUFF WILL INFLATE HIGHER IF THE PATIENT IS MORE HYPERTENSIVE AND LOWER IF THE PATIENT IS LESS HYPERTENSIVE. HIGHER PRESSURE GENERATED BY THE DEVICE WILL RESULT IN A TIGHTER OBSTRUCTION, WHEREAS LOWER PRESSURE WILL RESULT IN A LOOSER OBSTRUCTION. THUS, A TIGHTER OBSTRUCTION MAY LEAD TO A HIGHER CHANGE OF SKIN BRUISING AND FEELING DISCOMFORT OR A RESULTING BRUISE IS POSSIBLE FOR HYPERTENSION PATIENTS. THE PATIENT WHO REPORTED THIS INCIDENT¿S HYPERTENSIVE CONDITION IS UNKNOWN. THIS COMPLAINT IS CONFIRMED FOR BRUISING BUT NOT CONFIRMED FOR A DEVICE MALFUNCTION AS THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. H2H Q&R WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE BP CUFF CAUSED BRUISING ON A PATIENT AFTER USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542493 ECARECOMPANION ECAD BP MEDIUM/LG DXN VISICU, INC - DUP 453564551731 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other