BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECEPTAL 1.5 LITER PE/CE WITH (50/CASE)

    MDR report key: 1910420 · Received November 18, 2010

    Report

    Report Number
    9613251-2010-00154
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 19, 2010
    Manufacturer
    HOSPIRA LTD.
    Product Code
    GCX
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR INVESTIGATION. IF THE DEVICE IS RECEIVED, A F/U REPORT WILL BE SUBMITTED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER LISTED IN THE "OTHER" FIELD. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80GCX AND A 510K OF K831939. THE INFO ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED LOSS OF SUCTION. IT WAS REPORTED THAT DURING ENDOTRACHEAL ASPIRATION, IT WAS REPORTED THAT THE TUBING ON THE DEVICE COLLAPSED RESULTING IN LOSS OF SUCTION. REPORTEDLY, THE "PT NEARLY SUFFOCATED BUT EXPERIENCED NO HARM DUE TO QUICK INTERVENTION WITHOUT ANY INCIDENCE REPORTED." INFO WAS REQUESTED FROM THE CUSTOMER CONTACT REGARDING, HOW LONG THE SUCTION HAD BEEN IN USE, THE VACUUM SOURCE FOR THE SUCTION, PT OUTCOME, AND THE MEDICAL INTERVENTIONS PROVIDED; HOWEVER, NO ADDITIONAL INFO WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECEPTAL 1.5 LITER PE/CE WITH (50/CASE) UNK GCX HOSPIRA LTD. NA 90013KZ

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention