BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORATOR DRIVER W/HUDSON END

    MDR report key: 3060550 · Received April 10, 2013

    Report

    Report Number
    1045834-2013-01447
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    April 6, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBE
    PMA / PMN Number
    K042783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. RELIABILITY ENGINEERING EVALUATED THE DEVICE, AND THE REPORTED PROBLEM COULD NOT BE CONFIRMED OR DUPLICATED. THE DEVICE WAS TESTED AND PASSED ALL OPERATIONAL SPECIFICATIONS, INCLUDING TEMP ASSESSMENT, AND NO PROBLEMS WERE NOTED. IF ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6), STATING THE DEVICE WAS "HEATING". THE DEVICE WAS NOT BEING USED DURING A PROCEDURE. THE DATE OF THE EVENT IS UNK. NO PT OR USER INJURIES WERE REPORTED. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149651 PERFORATOR DRIVER W/HUDSON END HBE THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1