BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSENSOR BASIC KIT R

    MDR report key: 9173175 · Received October 9, 2019

    Report

    Report Number
    1226348-2019-00463
    Event Type
    Malfunction
    Date Received
    October 9, 2019
    Date of Event
    September 29, 2019
    Report Date
    September 30, 2019
    Manufacturer
    RAYNHAM
    Product Code
    GWM
    PMA / PMN Number
    K153347
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE MICROSENSOR WAS NOT RETURNED FOR EVALUATION; IT WAS DISCARDED AT THE HOSPITAL; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO ANOMALIES. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED. POSSIBLE ROOT CAUSE FOR THIS ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO INCORRECT SET-UP OF DEVICE. ADDITIONAL INFORMATION RECEIVED INDICATED, ¿THE PATIENT SUFFERED FROM SAB, WAS ALL THE TIME NOT CONSCIOUS AND DID NOT DEVELOP HIGH ICP WHILE THE PROBES WERE FUNCTIONING. THE REASON OF THE DEATH WAS NOT CAUSED BY THE MEASURING.¿

    Description of Event or Problem · 0

    N/A

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MICROSENSOR WORKED ONLY 1 DAY. AFTER THAT IS SHOWED NEGATIVE PRESSURE AND THAN NO DATA WERE GIVEN TO THE BEDSIDE MONITOR. THE PATIENT SUFFERED FROM SAB, WAS ALL THE TIME NOT CONSCIOUS AND DID NOT DEVELOP HIGH ICP WHILE THE PROBES WERE FUNCTIONING. THE REASON OF THE DEATH WAS NOT CAUSED BE THE MEASURING. THE PATIENT PASSED AWAY AND THE PROBE WAS DISCARDED. THE HOSPITAL STATED THAT THE MALFUNCTIONS OF THE SENSORS WERE NOT THE REASON FOR THE DEATH OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967402 MICROSENSOR BASIC KIT R ICP MICROSENSORS (ROHS) GWM RAYNHAM 178360

    Patients

    Seq Age Sex Outcome Treatment
    1 Death