BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 2442138 · Received February 1, 2012

    Report

    Report Number
    9610816-2012-00046
    Event Type
    Injury
    Date Received
    February 1, 2012
    Report Date
    January 17, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DXQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT WHEN A PATIENT'S BED WAS BEING MOVED, THE NON-INVASIVE BLOOD PRESSURE (NBP) TUBING RELEASED FROM THE NBP CUFF, AND THE METAL CONNECTOR (OF THE NBP TUBING) HIT THE NURSE'S LEFT EYE. A PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THE NBP TUBING CAME INTO CONTACT WITH THE BED RAIL, WHICH CAUSED THE CONNECTOR TO RELEASE FROM THE NBP CUFF. THERE WAS NO PRODUCT MALFUNCTION. THE REPORTED ISSUE IS CONSISTENT WITH THE NBP TUBING BEING UNDER TENSION AT THE TIME THE CONNECTOR WAS RELEASED, THEREBY CAUSING THE TUBING TO SNAP BACK. THE METAL CONNECTOR AT THE END OF THE TUBING THEN STRUCK THE NURSE'S LEFT EYE, CAUSING A CUT THAT REQUIRED SUTURES. THERE HAS BEEN NO REPORT THUS FAR OF ANY IMPACT TO THE NURSE'S EYESIGHT. THERE WAS NO PRODUCT MALFUNCTION. TRENDING ON THIS ISSUE SUPPORTS THAT THERE IS NO DESIGN, MANUFACTURING, MATERIALS, OR LABELING PROBLEM. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE A PATIENT WAS BEING MOVED, THE BED RAIL CONTACTED THE NBP TUBING/CONNECTOR, AND THE TUBING WAS RELEASED FROM THE CUFF. A NURSE SUSTAINED AN EYE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA NA DXQ PHILIPS MEDICAL SYSTEMS M1599B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention