BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK ICP EXPRESS

    MDR report key: 6205536 · Received December 27, 2016

    Report

    Report Number
    1226348-2016-10880
    Event Type
    Malfunction
    Date Received
    December 27, 2016
    Date of Event
    September 6, 2016
    Product Code
    GWM
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    IN THE LITERATURE SEARCH ¿SECONDARY INSULTS AND ADVERSE EVENTS DURING INTRAHOSPITAL TRANSPORT OF SEVERE TRAUMATIC BRAIN-INJURED PATIENTS¿ PUBLISHED NEUROCRIT CARE, DOI 10.1007/S12028-016-0291-5, IT WAS REPORTED THAT ONE UNKNOWN CODMAN MICROSENSOR SYSTEM HAD HARDWARE FAILURE DURING TRANSPORT OF A PATIENT. PER THE ARTICLE: ¿OUR AIM WAS TO ASSESS THE OCCURRENCE OF SECONDARY INSULTS (SIS) OR ADVERSE EVENTS (AES) DURING INTRAHOSPITAL TRANSPORT (IHT) OF SEVERE TRAUMATIC BRAIN INJURY (TBI) PATIENTS FOR HEAD COMPUTED TOMOGRAPHY (CT) SCANNING... IHT CARRIES SIGNIFICANT SIS AND AES IN SEVERE TBI PATIENTS. TO IMPROVE A RISK/BENEFIT RATIO FAVORABLE FOR PATIENTS, A PROGRAM FOCUSING ON IHT COMPLICATIONS REGARDING THERAPEUTIC IMPACT OF CONTROL CT SCAN IS NEEDED¿. TWENTY-FOUR AES OCCURRED DURING TRANSPORT OF 19 PATIENTS (61 %), AND 4 PATIENTS (13 %) HAD MORE THAN ONE AE DURING THE SAME TRANSPORT. IT WAS A VENTILATOR ASYNCHRONY IN 11 CASES (46 %), A HARDWARE FAILURE IN 7 CASES (29 %) (4 INFUSION PUMPS, 1 ICP MONITOR, AND 2 PORTABLE VENTILATORS), AN UNPLANNED WITHDRAWAL OF EQUIPMENT IN 3 CASES (13 %) (DRAINAGE LINE, PERIPHERAL VENOUS ACCESS, DRESSING) AND IN 3 CASES (13 %) AN EQUIPMENT DISCONNECTION (2 DISCONNECTIONS OF THE VENTILATOR AND A DISCONNECTION OF THE PIC SENSOR). NO CASE OF UNPLANNED EXTUBATION WAS REPORTED.¿ THERE IS NO REPORT OF INTERVENTION PERFORMED FOR THE EVENT OF HARDWARE FAILURE. THERE IS NO PATIENT SPECIFIC INFORMATION AVAILABLE. AT THE TIME OF COMPLAINT ENTRY NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856598 UNK ICP EXPRESS DEVICE, INTRACRANIAL PRESSURE MONITORING GWM

    Patients

    Seq Age Sex Outcome Treatment
    1