BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKMAX-NEURO LOW PRESSURE

    MDR report key: 7050599 · Received November 21, 2017

    Report

    Report Number
    1045834-2017-50013
    Event Type
    Malfunction
    Date Received
    November 21, 2017
    Report Date
    October 27, 2017
    Manufacturer
    THE ANSPACH EFFORT LLC
    Product Code
    HBB
    PMA / PMN Number
    K831756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS MEDWATCH, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL NARRATIVE: IT WAS ERRONEOUSLY REPORTED IN THE INITIAL MEDWATCH REPORT THAT THE REPORTED CONDITION OF HEAT WAS CONFIRMED. UPON FURTHER INVESTIGATION OF THE DEVICE EVALUATION, IT WAS DETERMINED THAT THE REPORTED CONDITION WAS NOT CONFIRMED. THEREFORE, THE ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. HOWEVER, DURING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD AN INSUFFICIENT/LOW POWER DUE TO COMPONENT FAILURE FROM NORMAL WEAR. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    UDI: GTIN IS UNAVAILABLE AS THE PRODUCT MADE PRIOR TO COMPLIANCE DATE; (B)(4). (B)(6). THIS DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. DURING REPAIR, IT WAS DETERMINED THAT THE REPORTED CONDITION WAS CONFIRMED. IT WAS DETERMINED THAT THE BEARINGS WERE WORN. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO WEAR FROM NORMAL USE AND SERVICING. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT THE MOTOR DEVICE GENERATED HEAT AND HAD A SHORTAGE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828407 BLACKMAX-NEURO LOW PRESSURE MOTOR, DRILL, PNEUMATIC - HANDPIECE HBB THE ANSPACH EFFORT LLC

    Patients

    Seq Age Sex Outcome Treatment
    1