BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROTARGETING GUIDELINE 4000 LP+ CABLE

    MDR report key: 2564039 · Received May 2, 2012

    Report

    Report Number
    3005677147-2012-00004
    Event Type
    Other
    Date Received
    May 2, 2012
    Date of Event
    April 13, 2012
    Report Date
    April 13, 2012
    Manufacturer
    FHC, INC
    Product Code
    GZL
    PMA / PMN Number
    K071364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL RISK ANALYSIS WAS PERFORMED AND IT WAS FOUND THAT THE POWER CORD SHIPPED WITH THE LP+ SYSTEM WAS INDEED NON-MEDICAL GRADE. IT WAS NOTED THAT THE NON-MEDICAL GRADE POWER CORD DID NOT POSE A RISK TO THE PT NOR DID IT AFFECT THE PERFORMANCE, THE SAFETY OR EFFICACY OF THE SYSTEM. THE NON-MEDICAL GRADE POWER CORDS WHICH WERE LABELLED AS MEDICAL GRADE WERE SOLD ALONG WITH THE MT-LPP SYSTEM SINCE 10/2010. UPON CONTACTING (B)(4), IT WAS LEARNT THAT THE GRADE OF THE POWER CORD WAS OVERLOOKED DURING THE ORIGINAL PRODUCT EVALUATION. INITIAL TESTING ON THE SYSTEM WAS PERFORMED USING THREE DIFFERENT POWER CORDS, INCLUDING THE NON MEDICAL GRADE AND THE HOSPITAL GRADE POWER CORD. FHC HAS DECIDED TO CONDUCT A MARKET WITHDRAWAL FOR THE NON MEDICAL GRADE POWER CORDS AND REPLACE THEM WITH HOSPITAL GRADE POWER CORDS AS REQUIRED IN (B)(4). FHC WILL DELIVER REPLACEMENT LINE CORDS TO THE AFFECTED FACILITIES IN PERSON.

    Description of Event or Problem · 1

    FHC TECHNICAL SUPPORT REPRESENTATIVE REPORTED TO FHC, AN INCIDENT WHERE THE LP+ POWER CORD WAS NOT USED BECAUSE IT WAS NOT MEDICAL GRADE. THE SURGERY WAS COMPLETED SUCCESSFULLY USING ANOTHER MEDICAL GRADE POWER CORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROTARGETING GUIDELINE 4000 LP+ CABLE LP+ CABLE GZL FHC, INC MT-LPP-LC-USA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK