BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHS MICROSENSOR BASIC KIT

    MDR report key: 5769106 · Received July 5, 2016

    Report

    Report Number
    1226348-2016-10466
    Event Type
    Injury
    Date Received
    July 5, 2016
    Date of Event
    June 16, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GWM
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED UDI -- (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY THE SUPPLIER. A REVIEW OF QUALITY RECORDS FOUND THAT THE DEVICE MET MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS PRIOR TO DISTRIBUTION. EVALUATION OF THE RETURNED DEVICE FOUND NO VISIBLE DAMAGE TO THE SENSOR CATHETER MATERIAL OR CONNECTOR. DURING THE INITIAL TESTING, THE REPORTED ISSUE OF SHOWING AN ICP OF 130 COULD NOT BE CONFIRMED. HOWEVER, DURING TESTING THE SENSOR STOPPED FUNCTIONING AND COULD NOT BE ADJUSTED. WHILE THE INITIAL COMPLAINT COULD NOT BE CONFIRMED, AN ISSUE WITH THE SENSOR WAS IDENTIFIED. THE SUPPLIER DETERMINED THAT THE ISSUE WAS RELATED TO THE PRESSURE SENSOR. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 1

    THE 510(K) # OF SIMILAR PRODUCT CODE OF 826631: K914479. (B)(4). UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AN ICP PROBE (CODE 626631) WAS JUST SHOWING AN ICP OF 130 AND NOT CHANGING EVEN WHEN NOT INSERTED. NO ADDITIONAL INFORMATION GIVEN. PER REP: DID THIS EVENT OCCUR INTRA-OPERATIVELY: NO, IT STARTED MALFUNCTIONING IN THE WARD. DID THE REPORTED EVENT CAUSE ANY DELAYS IN THE SURGERY OR PROCEDURE OVER 30 MINUTES: PATIENT HAD TO GO BACK TO THEATRE FOR A NEW ICPM. WERE THERE ANY ADVERSE CONSEQUENCES TO THE PATIENT: A SECOND OPERATION. WHAT ACTIONS WERE TAKEN AS A RESULT OF THIS INCIDENT: AS ABOVE. WAS THE DEVICE REVISED OR WAS IT REMOVED AND MONITORING DISCONTINUED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423601 ROHS MICROSENSOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention