BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 3790018 · Received May 5, 2014

    Report

    Report Number
    1226348-2014-11518
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    October 28, 2012
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    GWM
    PMA / PMN Number
    PK914479
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE SUPPLIER PERFORMED THIS EVALUATION DURING THE EVALUATION A REVIEW OF THE QUALITY RECORDS WAS CONDUCTED AND PRIOR TO DISTRIBUTION THIS DEVICE MET ALL MANUFACTURING AND TESTING/INSPECTION SPECIFICATIONS. THE CATHETER WAS EVALUATED AND THE FOLLOWING OBSERVATIONS NOTED: COSMETIC LIFTING OF SEALANT AT SENSOR AREA. CATHETER MATERIAL KINKED 3.1CM FROM SENSOR CASE. MULTIPLE SLIGHT BENDS ALONG CATHETER BODY. CATHETER RECEIVED WITH SUTURE ATTACHED. THE SENSOR PASSED ELECTRONIC, NOISE, LINEARITY/HYSTERESIS, AND SIGNAL DRIFT TESTS. MFG. DATE: 4/23/12. BASED ON THE ABOVE EVALUATION SUPPLIER WAS UNABLE TO CONFIRM THE COMPLAINT. BASED ON THE INVESTIGATION THIS COMPLAINT IS CONSIDERED CLOSED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR EVENTS.

    Description of Event or Problem · 1

    DURING INSERTION OF MICROSENSOR WORKED OK, GAVE REF #. PATIENT THEN WAS TRANSFERRED FROM RECOVERY TO ICU. JUST BEFORE ENTERING UNIT, ONE OF THE NURSES NOTICED THAT THERE WAS A MSG ON ICP UNIT SAYING 'NO TRANSDUCER DETECTED'. STAFF CALLED (B)(4), AND THEY WENT TO PATIENT CHECKED ALL CONNECTIONS AND ALL LOOKED OK. ALTHOUGH THE ERROR MSG WAS STILL THERE. (B)(4) BELIEVED TIP WAS IN RIGHT LOCATION. AS IT WAS SUTURED FIRMLY IT SHOULDN'T HAVE MOVED. THEN CHANGED TO ANOTHER CABLE AND STILL HAD ERROR. THEN TRIED ANOTHER BOX AND CABLE AND GOT -65 READING, THE CORRECT REF # WAS ENTERED . STAFF WAITED TO SEE HOW PATIENT WAS WHEN HE AWOKE. PATIENT WAS NEUROLOGICALLY OK THEREFORE THE MICROSENSOR WAS REMOVED. PRODUCT WILL BE RETURNED. PS WILL VISIT HOSPITAL ON WEDNESDAY 31.10.2012 AND CALL WITH COLLECTION DETAILS. PATIENT IS OK. NO ADVERSE EVENT REPORTED AS A RESULT OF THIS INCIDENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268474 NEUROMONITOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF CNGBB3

    Patients

    Seq Age Sex Outcome Treatment
    1 82-6635| 82-6636