BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUMO SURE XL HIGH FLOW INSUFFLATOR

    MDR report key: 3221394 · Received July 11, 2013

    Report

    Report Number
    0002936485-2013-00285
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HIF
    PMA / PMN Number
    K063367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS PHYSICALLY RETURNED, HOWEVER, IT WAS REPAIRED AND RETURNED TO THE CUSTOMER BEFORE AN ENGINEER WAS ABLE TO PERFORM A FULL EVALUATION. THEREFORE, THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. BASED ON THE REPAIR DIAGNOSTIC CODES THE UNIT WAS SUBMITTED FOR CALIBRATION AND FULL FUNCTIONAL TESTS AND ANY BAD COMPONENTS WERE REPAIRED/REPLACED. PAST COMPLAINTS INVOLVING THIS PRODUCT AND THIS REPORTED FAILURE, HAVE BEEN PRIMARILY CAUSED BY: BAD LPU/HPU, BAD PRESSURE SENSORS OR PRESSURE CONTROL VALVES AND/OR USER ERROR. IN SUM, THE PRODUCT WAS PHYSICALLY RETURNED BUT THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT CONSTANTLY BEEPED AND INDICATED OVER PRESSURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT CONSTANTLY BEEPED AND INDICATED OVER PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319926 PNEUMO SURE XL HIGH FLOW INSUFFLATOR INSUFFLATOR, LAPAROSCOPIC HIF STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1