BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKMAX-NEURO

    MDR report key: 2896664 · Received December 28, 2012

    Report

    Report Number
    1045834-2012-00185
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HSZ
    PMA / PMN Number
    K955084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE "HOSE WAS DAMAGED." THE HOSE HAD A TEAR AND IT WAS FOUND DURING PRETESTING. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO INJURIES REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLACKMAX-NEURO HSZ THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1