BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSION PICCO MONITORING KIT

    MDR report key: 6128480 · Received November 28, 2016

    Report

    Report Number
    3003263092-2016-00016
    Event Type
    Malfunction
    Date Received
    November 28, 2016
    Date of Event
    October 11, 2016
    Report Date
    January 30, 2017
    Manufacturer
    PULSION MEDICAL SYSTEMS SE
    Product Code
    KRB
    PMA / PMN Number
    K991886
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MONITORING KIT ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION. DURING INVESTIGATION AT THE SUPPLIER, A LEAK TEST WAS PERFORMED AND NO LEAKS WERE DETECTED. A COSMETIC ISSUE WAS IDENTIFIED, THAT DOES NOT AFFECT THE FUNCTION OF THE SENSOR. THIS ISSUE IS REGARDED AS SINGLE ISSUE. THE ERROR WILL BE MONITORED FOR TRENDS. NO SIMILAR COMPLAINT WITHIN THE LAST 12 MONTHS WAS DETECTED. PLEASE NOTE, MAQUET MEDICAL SYSTEMS USA (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF PULSION MEDICAL SYSTEMS SE (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVOLVED MONITORING KIT WAS RETURNED FOR INVESTIGATION AND INVESTIGATION IS ONGOING. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE # : (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CRACK IN THE PRESSURE TRANSDUCER WAS FOUND PRIOR TO USE BY A NURSE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780725 PULSION PICCO MONITORING KIT PROBE, THERMODILUTION KRB PULSION MEDICAL SYSTEMS SE

    Patients

    Seq Age Sex Outcome Treatment
    1