BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BMF FOOTSWITCH

    MDR report key: 12821437 · Received November 16, 2021

    Report

    Report Number
    2027754-2021-00023
    Event Type
    Malfunction
    Date Received
    November 16, 2021
    Report Date
    March 21, 2022
    Manufacturer
    OSTEOMED, LLC
    Product Code
    GBB
    UDI-DI
    00845694012614
    PMA / PMN Number
    971692
    Removal / Correction Number
    2027754-10/22/21-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    H6: TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSION UPDATED TO REFLECT DEVICE EVALUATION. THE DEVICE WAS RETURNED FOR EVALUATION. THE INVESTIGATION REVEALED THE REPORTED EVENT COULD NOT BE REPRODUCED UNTIL THE RETURNED CABLE WAS CRIMPED. THE UNIT WAS CONTINUOUS(LY) RUNNING SOMETIMES POTENTIALLY DUE TO A MALFUNCTION CABLE ASSEMBLY 7 PINS CONNECTOR. THE RETURNED CABLE HAD NO CUTS OR DAMAGE. DUE TO UNKNOWN PROCEDURAL CONDITIONS HOWEVER, THE CAUSE OF THE REPORTED EVENT IS UNKNOWN. THIS REPORT IS RELATED TO REPORT NUMBER 2027754-2021-00021 FOR THE MOTOR UNIT AND 2027754-2021-00022 FOR THE CONSOLE. THE DHR WAS REVIEWED FOR THE REPORTED LOT NUMBER AND ALL INSPECTIONS PASSED PER THE DHR.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ON GOING AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 0

    ON (B)(6) 2021, THE CUSTOMER CONTACTED OSTEOMED PRODUCT MANAGER BY EMAIL. PER THE EMAIL: "THE CONSOLE UNIT WILL SPONTANEOUSLY BEGIN RUNNING ON REVERSE, WITHOUT ANYONE PRESSING THE FOOT PEDAL! " THE INVOLVED PART NUMBERS ARE AS FOLLOWS: COMPLAINT #, PART #, DESCRIPTION, SERIAL #; 211008, 450-0084, SERIES II LOW PROFILE MODULAR MOTOR UNIT, (B)(4). 210819, 450-0021, POWER CONTROL CONSOLE 2, (B)(4). 210820, 450-0390, BMF FOOTSWITCH, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1721448 BMF FOOTSWITCH BMF FOOTSWITCH GBB OSTEOMED, LLC 450-0390 00845694012614

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown