BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES II LOW PROFILE MODULAR MOTOR UNIT

    MDR report key: 12389476 · Received August 30, 2021

    Report

    Report Number
    2027754-2021-00015
    Event Type
    Malfunction
    Date Received
    August 30, 2021
    Report Date
    June 30, 2022
    Manufacturer
    OSTEOMED, LLC
    Product Code
    GBB
    UDI-DI
    00845694012263
    PMA / PMN Number
    971692
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THIS REPORT IS RELATED TO REPORT NUMBERS 2027754-2021-00013 AND 2027754-2021-00014 WHICH ARE FOR THE CONSOLE AND BMF FOOTSWITCH INVOLVED IN THIS EVENT. THE CONSOLE 450-0021-00 SN (B)(6), FOOTSWITCH 450-0390 SN (B)(6), AND MOTOR UNIT 450-0084 SN (B)(6) WERE RETURNED FOR EVALUATION.THE CONSOLE 450-0021-00 SN: (B)(6) WAS MANUFACTURED UNDER LOT 1055201. A TOTAL OF (B)(4) UNITS WERE MANUFACTURED UNDER THIS LOT NUMBER. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ISSUES WERE IDENTIFIED. THE UNIT PASSED ALL INSPECTIONS. THE MOTOR UNIT 450-0084, SN:(B)(6) WAS MANUFACTURED UNDER LOT# 1022389. THE DHR WAS REVIEWED, AND NO ISSUES WERE IDENTIFIED FOR SN: (B)(6). ALL INSPECTIONS PASSED FOR THIS UNIT. THE FOOTSWITCH 450-0390 SN (B)(6) WAS MANUFACTURED UNDER LOT 1053682 . A TOTAL OF (B)(4) UNITS WERE MANUFACTURED UNDER THIS LOT NUMBER. THE DHR WAS REVIEWED, AND NO ISSUES WERE IDENTIFIED. THE UNIT PASSED ALL INSPECTIONS. EVALUATION OF THE RETURNED DEVICES WERE PERFORMED. INITIAL REVIEW DID NOT SHOW ANY EXTERNAL SIGNS OF DAMAGE. VISUAL VERIFICATION (EXTERNAL) DID NOT IDENTIFY ANYTHING UNUSUAL OTHER THAN THE MOTOR UNIT HAD A GAP ON THE HOUSING WHICH WAS MORE THAN USUAL. DEVICE WAS POWERED ON AND TURNED ON AND WAS FUNCTIONING AS EXPECTED. FOR FURTHER ELECTROMAGNETIC EMISSIONS ANALYSIS THE DEVICE WAS TAKEN TO 3RD PARTY TEST FACILITY (NTS TESTING, INSPECTION AND CERTIFICATION). A PRELIMINARY REVIEW FOR ANY ELECTROMAGNETIC EMISSIONS AT NORMAL TURN ON, FORWARD AND REVERSE RUNNING, USING A DETECTOR/OSCILLOSCOPE DID NOT DETECT ANY INTERFERENCES. REVIEW OF THE USER MANUAL INDICATED THERE IS GUIDANCE AND MANUFACTURER'S DECLARATION ON ELECTROMAGNETIC EMISSIONS. THE ANALYSIS PERFORMED AS DETAILED ABOVE DID NOT IDENTIFY A FAILURE IN THE SYSTEM. IRRESPECTIVE OF THIS CONCLUSION THE CONSOLE AND FOOTSWITCH HAVE BEEN RECALLED (RECALL NUMBER: (B)(4) AS INDICATED IN FOLLOW UP 1 REPORTS FOR 2027754-2021-00013 AND 2027754-2021-00014) . IT WAS VERIFIED WITH THE RECALL TEAM THAT THE CUSTOMER ADVANCED DENTAL FACILITIES HAVE BEEN NOTIFIED OF THIS RECALL AND THEY HAVE CONFIRMED THEY DO NOT HAVE ANY OTHER RECALL PRODUCTS IN THEIR LOCATION. THE PRODUCTS RETURNED PER THIS COMPLAINT WILL BE PROCESSED PER THE RECALL PRODUCT DISPOSITION.

    Description of Event or Problem · 0

    ON (B)(6) 2021, THE CUSTOMER CONTACTED OSTEOMED PRODUCT MANAGER, REPORTING THAT THE OSTEOMED 450-0021, POWER CONTROL CONSOLE 2 WITH SERIAL NUMBER (B)(4) WAS INTERFERING WITH GE INTERCARE AND CRITICARE MONITORS. THE INVOLVED PART NUMBERS ARE AS FOLLOWS: COMPLAINT # PART # DESCRIPTION SERIAL # (B)(4), 450-0021, POWER CONTROL CONSOLE 2, (B)(4). (B)(4). 450-0390, BMF FOOTSWITCH, (B)(4). (B)(4), 450-0084, SERIES II LOW PROFILE MODULAR MOTOR UNIT, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286419 SERIES II LOW PROFILE MODULAR MOTOR UNIT SERIES II LOW PROFILE MODULAR MOTOR UNIT GBB OSTEOMED, LLC 450-0084 00845694012263

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown