BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSEMBLY 22MM CKT DUAL SPU

    MDR report key: 5324702 · Received December 23, 2015

    Report

    Report Number
    8030673-2015-00147
    Event Type
    Malfunction
    Date Received
    December 23, 2015
    Date of Event
    October 15, 2015
    Report Date
    December 8, 2015
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K070594
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER FACILITY MEDWATCH INITIALLY INDICATED THAT THIS MALFUNCTION INVOLVED PRODUCT CODE 18221-101. UPON RECEIPT OF THE PRODUCT BY CAREFUSION IT WAS CONFIRMED THAT THE ACTUAL PRODUCT NUMBER WAS ISG2026031. ISG2026031 IS DISTRIBUTED BY CAREFUSION FOR (B)(4) IS THE LEGAL MANUFACTURE AND OWNS DESIGN AND REGULATORY PATHWAY FOR THIS PRODUCT. CAREFUSION DOES NOT OWN THE DESIGN, SPECIFICATIONS, OR REGULATORY PATHWAY FOR THIS DEVICE. IN ADDITION, THE DEVICE IS NOT MARKETED BY CAREFUSION. INTERSURGICAL INC. HAS BEEN NOTIFIED OF THIS EVENT. MDR REPORTING WOULD BE PERFORMED BY INTERSURGICAL INC. (IF DEEMED NECESSARY, BASED ON THEIR PROCEDURES).

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL EMDR SUBMISSION. IT HAS BEEN CONFIRMED THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR EVALUATION. ATTEMPTS HAVE BEEN MADE BY CUSTOMER ADVOCACY TO GAIN ADDITIONAL INFORMATION FROM THE CUSTOMER AND END USER REGARDING SITUATION REPORTED WITH DEVICE. CUSTOMER ADVOCACY IS STILL WAITING FOR ADDITIONAL INFORMATION REGARDING REPORTED ISSUE. IF A SAMPLE OR ANY ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP EMDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA MEDWATCH REPORT (B)(4). PATIENT WAS ON FACEMASK VENTILATION. THE CIRCUIT CONNECTION ON THE FRONT OF THE DEVICE BECAME DISCONNECTED. THE PATIENT WAS NOT OXYGENATING AND HIS PULSE OXYGENATION DECREASED INTO THE MID 60'S. THE PATIENT REQUIRED EXCESSIVE BAGGING AND INTUBATION. THIS INVOLVED THE FAILURE OF THE INTERSURGICAL CIRCUITS OF WHICH OUR CAREFUSION REP REMOVED ALL FROM OUR INVENTORY AND REPLACED WITH THE RT380. WE DID NOT KEEP THE CIRCUIT IN QUESTION BELOW. THERE IS NO PART TO RETURN. INTERSURGICAL HAS ALREADY SENT ME A LETTER TELLING ME THEY COULD NOT REPLICATE THE ISSUE IN THEIR LAB FROM THE 13+ CASES WE RETURNED TO CAREFUSION WHO RETURNED TO INTERSURGICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850173 ASSEMBLY 22MM CKT DUAL SPU VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION 18221-101 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1