BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARENCHYMAL PRESSIO CATHETER 2

    MDR report key: 7880531 · Received September 17, 2018

    Report

    Report Number
    3001587388-2018-18361
    Event Type
    Malfunction
    Date Received
    September 17, 2018
    Date of Event
    July 21, 2018
    Report Date
    September 17, 2018
    Manufacturer
    SOPHYSA
    Product Code
    GWM
    PMA / PMN Number
    K162108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE ARE RE-SUBMITTING THIS REPORT PER FOLLOWING REQUEST BY FDA: IT APPEARS THAT THESE SUPPLEMENT REPORTS COULD BE ACTUAL INITIAL REPORTS THAT MAY HAVE BEEN ERRONEOUSLY SUBMITTED AS FOLLOW-UPS IN ERROR DUE TO CHECKING BOTH INITIAL BOX AND FOLLOW-UP BOX IN 3001587388-2018-18361 - 1. LOT #: E0364. RESUBMIT AS INITIAL

    Description of Event or Problem · 0

    PATIENT BECAME VERY RESTLESS AND AGITATED. AFTER PATIENT WAS MEDICATED AND SETTLED DOWN, NURSE NOTICED ICP NO LONGER READING. MONITOR BEGAN TO SOUND A CONTINUOUS ALARM. NURSE TRIED TO TROUBLESHOOT, I.E MAKING SURE CATHETER STILL ATTACHED TO PATIENT, MAKING SURE CATHETER ATTACHED TO MACHINE, TURNING ON OFF. PRESSIO CONSULTANT WAS THEN CONTACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724832 PARENCHYMAL PRESSIO CATHETER 2 ICP PRESSURE MONITORING CATHETER GWM SOPHYSA ICP CATHETER E0364

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other