BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH MRI SET: HANDLE+ MIL 0,1 MAC 2,3,4

    MDR report key: 11859058 · Received May 20, 2021

    Report

    Report Number
    8030121-2021-00020
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Date of Event
    May 5, 2021
    Report Date
    May 5, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCW
    UDI-DI
    14026704712530
    PMA / PMN Number
    K062523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE SAMPLE WAS RETURNED AND SENT TO THE MANUFACTURING SITE FOR INVESTIGATION. THE DEVICE HISTORY RECORD OF LOT 161102 WAS REVIEWED AND NO ISSUE THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE WAS NOTED. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION. THE MANUFACTURING SITE REPORTS "DURING INVESTIGATION IT IS IDENTIFY THAT BATTERY CARTRIDGES HAS FOUND OUT OF WARRANTY PERIOD & HAD EXCEEDED THE SELF-LIFE OF 18 MONTHS AT THE TIME OF COMPLAINT REPORTED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "DURING THE FIRST USE, WE OBSERVED THAT 3 BATTERIES OUT OF 4 THAT ARE IN THE KIT WERE NOT WORKING. THE BLADES HAVE LIGHT ONLY WITH 1 OF THE BATTERIES. NO LIGHT WITH THE OTHER 3 BATTERIES". NO PATIENT INVOLVEMENT REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "DURING THE FIRST USE, WE OBSERVED THAT 3 BATTERIES OUT OF 4 THAT ARE IN THE KIT WERE NOT WORKING. THE BLADES HAVE LIGHT ONLY WITH 1 OF THE BATTERIES. NO LIGHT WITH THE OTHER 3 BATTERIES". NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750738 RUSCH MRI SET: HANDLE+ MIL 0,1 MAC 2,3,4 LARYNGOSCOPE, RIGID CCW TELEFLEX MEDICAL IPN915573 161201 14026704712530

    Patients

    Seq Age Sex Outcome Treatment
    1