BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA XL

    MDR report key: 2182105 · Received June 23, 2011

    Report

    Report Number
    1220063-2011-00032
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 28, 2011
    Report Date
    June 3, 2011
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC. (IT/M)
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DRAEGER IS STILL INVESTIGATING THE REPORTED INCIDENT. A FOLLOW-UP REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT MONITORING SYSTEM DID NOT ALARM AND THE ARTERIAL TUBING MANUFACTURED BY SMITHS MEDICAL WAS BROKEN. THE CUSTOMER ALSO REPORTED THAT THE ARTERIAL LINE TRACE WAS FLAT WITH NO PRESSURE DUE TO THE BROKEN ARTERIAL TUBING. THE ARTERIAL TUBING WAS REQUESTED BY DRAEGER SERVICE. HOWEVER, IT WAS ALREADY DISPOSED OF BY THE CUSTOMER. THERE WAS A PT INJURY REPORTED. DRAEGER REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA XL PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. (IT/M) UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention NO