BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8300 ALARIS ETCO2 MODULE

    MDR report key: 11032686 · Received December 17, 2020

    Report

    Report Number
    2016493-2020-70409
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Report Date
    July 11, 2019
    Manufacturer
    CAREFUSION SD
    Product Code
    CCK
    UDI-DI
    10885403830013
    PMA / PMN Number
    K031741
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTED EVENT AND SUBSEQUENT REPAIRS WERE INVESTIGATED THROUGH THE TSC TROUBLESHOOTING PROCESS. A REVIEW OF THE DEVICE SERVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE CORRESPONDING TO THIS SERVICE NOTIFICATION NUMBER. THE DATABASE SHOWED NO QUALITY NOTIFICATIONS WERE OPENED FOR THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(4) WAS PERFORMED FROM THE DATE OF THE MANUFACTURE TO DATE OF THE RELEASE OF PRODUCT, WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE, AND PRODUCT WAS NOT RETURNED FOR SERVICING WHICH NOT CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY RECORD IN THE TRACKWISE WAS PERFORMED FOR THE SN (B)(4) WHICH CONFIRMED NO SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    CASE #: (B)(4). CASE SUBJECT: NPI 8300 ERROR 571.6240. ACCOUNT NAME: (B)(4) MEDICAL CENTER. ACCOUNT #: (B)(4). ASSET NAME: 8300 ETCO2 MODULE, V8. ASSET LOCATION: CONTACT: (B)(6). CONTACT EMAIL: (B)(6). CONTACT PHONE: (B)(6). CONTACT MOBILE: PATIENT OR USER INVOLVEMENT: NO. PATIENT OR USER HARM: NO. CASE DESCRIPTION: (B)(6) HAD ERROR 571.6240 ON ETCO2 MODULE SN (B)(4). FAILURE DEVICE TYPE: ALARIS SYSTEM INSTRUMENT, FAILURE PROBLEM TYPE: 8300, FAILURE MODE: TROUBLESHOOTING/ ERROR CODES. CASE RESOLUTION: I RECOMMENDED SAM TO RE-SEAT THE ORIDION BOARD HARNESSES. IF RE-SEATING HARNESSES DID NOT RESOLVE THE ISSUE, SAM WILL REPLACE ORIDION MODULE KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1494541 8300 ALARIS ETCO2 MODULE PUMP, INFUSION CCK CAREFUSION SD 8300 10885403830013

    Patients

    Seq Age Sex Outcome Treatment
    1