BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 5879735 · Received August 16, 2016

    Report

    Report Number
    2936999-2016-00641
    Event Type
    Malfunction
    Date Received
    August 16, 2016
    Date of Event
    July 21, 2016
    Report Date
    July 21, 2016
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MODEL PART NUMBER 107-75 IS NOT SOLD IN THE US. SIMILAR PART 86451 HI CONTOUR IS SOLD IN THE US UNDER 510K NO. K965132.

    Description of Event or Problem · 1

    DURING PRETEST THE CUFF DID NOT INFLATE. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532823 MALLINCKRODT 7.5MM HI CONTOUR 86451 X10 BTR COVIDIEN 107-75 15276046FENX

    Patients

    Seq Age Sex Outcome Treatment
    1