BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS GO POWER SUPPLY

    MDR report key: 3963040 · Received July 29, 2014

    Report

    Report Number
    3006760724-2014-00400
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    June 30, 2014
    Report Date
    December 10, 2014
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K083375
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTIVE INVESTIGATION IN PROGRESS; RESULTS OF INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENT REPORT.

    Description of Event or Problem · 1

    ELECTRICAL SHORT. NURSE CONNECTED THE POWER CORD WITH THE POWER SUPPLY. THE POWER CORD WAS ALREADY PLUGGED IN THE PLUG SOCKET. HE RECEIVED AN ELECTRIC SHOCK IN THE HAND. CABLE CORD WAS NOT YET CONNECTED WITH THE RENASYS DEVICE. INCIDENT WAS INVESTIGATED IN THE AMBULANCE OF THE HOSPITAL.

    Description of Event or Problem · 1

    NURSE CONNECTED THE POWER CORD WITH THE POWER SUPPLY. THE POWER CORD WAS ALREADY PLUGGED IN THE PLUG SOCKET. HE RECEIVED AN ELECTRIC SHOCK IN THE HAND. CABLE CORD WAS NOT YET CONNECTED WITH THE RENASYS DEVICE. INCIDENT WAS INVESTIGATED IN THE AMBULANCE OF THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441745 RENASYS GO POWER SUPPLY PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH & NEPHEW WOUND MANAGEMENT 66800164

    Patients

    Seq Age Sex Outcome Treatment
    1