BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPPHIRE

    MDR report key: 4182159 · Received September 25, 2014

    Report

    Report Number
    4182159
    Event Type
    Malfunction
    Date Received
    September 25, 2014
    Date of Event
    August 14, 2014
    Report Date
    September 25, 2014
    Manufacturer
    Q CORE MEDICAL LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE PUMP'S CHARGER IS THE TYPE THAT IS A TRANSFORMER/WALL PLUG ASSEMBLY. IT TAKES THE 110V AC AND PROVIDES LOW VOLTAGE OUT VIA A THIN TWIN CONDUCTOR CORD WITH A CONNECTOR THAT MATES WITH THE CONNECTOR IN THE PUMP. THE 110V PLUG IS A MULTIADAPTOR TYPE WHERE SMALL DIFFERING PLUG ASSEMBLIES CAN BE EXCHANGED ON THE TRANSFORMER/PLUG BODY. THE US 110V AC PLUG ADAPTOR IS DELICATE AND BREAKS EASY. IT BROKE AND LEFT THE 110V CONDUCTOR PIN IN THE WALL WITH THE CONDUCTOR PARTIALLY EXPOSED. A TECHNICIAN WAS QUICKLY SUMMONED AND REMOVED IT. ALL UNITS WERE INSPECTED AND OKAY, BUT THE POTENTIAL FOR MORE OCCURRENCES REMAINS.MANUFACTURER RESPONSE FOR EPIDURAL PUMP, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================THE CHARGER IS NOT COVERED UNDER WARRANTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596858 SAPPHIRE PUMP, INFUSION FRN Q CORE MEDICAL LTD. SAPPHIRE *

    Patients

    Seq Age Sex Outcome Treatment
    1 *