BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLO II

    MDR report key: 8342361 · Received February 15, 2019

    Report

    Report Number
    9617473-2018-00008
    Event Type
    Malfunction
    Date Received
    February 15, 2019
    Manufacturer
    STIHLER ELECTRONIC GMBH
    Product Code
    KOC
    PMA / PMN Number
    K082758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATIONS ARE NOT POSSIBLE AS THE DEFECTIVE DEVICE WAS NOT AVAILABLE FOR INVESTIGATION AND S/N OF DEFECTIVE DEVICE WAS NOT TRANSMITTED. FROM THE EVENT DESCRIPTION THE DEVICE REACTED WITH AN ALARM AND HEATER CUT OFF AS INTENDED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENT REPORT WILL BE SUBMITTED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THE PRISMAFLO II WAS TURNED ON, IT WAS CONTINUOUSLY BEEPING. AFTER PRESSING THE START BUTTON IT STARTED FLASHING E26. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136739 PRISMAFLO II BLOOD WARMER KOC STIHLER ELECTRONIC GMBH PF2-265NA

    Patients

    Seq Age Sex Outcome Treatment
    1