BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SEDI-40

    MDR report key: 11314399 · Received February 11, 2021

    Report

    Report Number
    2243072-2021-00313
    Event Type
    Malfunction
    Date Received
    February 11, 2021
    Date of Event
    January 21, 2021
    Report Date
    February 19, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    JPH
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: INSTRUMENT SEDI 40 17- 42019 WAS RETURNED TO THE MANUFACTURER FOR SERVICE WITH RESPECT TO THE REPORTED DEFECTS ¿ NOISY, BROKEN PLATE, AND NO HOST COMMUNICATION. THE INSTRUMENT WAS EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING AND THE REPORTED DEFECTS WERE CONFIRMED. THE FAN WAS REPLACED, THE BROKEN PLATE WAS REPLACED, AND THE HOST COMMUNICATION WAS RE-ESTABLISHED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD SEDI-40 INFORMATION IS NOT BEING SENT TO LIS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SEDI DOES NOT SEND DATA TO LIS, I HAVE CHECKED WITH OTHER ANALYZER FOR THIS SPECIFIC LIS AND THE OTHER ANALYZER DOES, SO I ASSUME THAT THERE IS AND ISSUE WITH THIS ONE: (B)(6).

    Additional Manufacturer Narrative · 1

    FOR OEM MANUFACTURING SITES: IN THIS MDR, BD CORPORATE HEADQUARTERS IN (B)(4), HAS BEEN LISTED AS (B)(4) IS AN OEM MANUFACTURING SITE. MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING WITH BD SEDI-40 INFORMATION IS NOT BEING SENT TO LIS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SEDI DOES NOT SEND DATA TO LIS, I HAVE CHECKED WITH OTHER ANALYZER FOR THIS SPECIFIC LIS AND THE OTHER ANALYZER DOES, SO I ASSUME THAT THERE IS AND ISSUE WITH THIS ONE: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216522 BD SEDI-40 ESR INSTRUMENT JPH BECTON DICKINSON NA

    Patients

    Seq Age Sex Outcome Treatment
    1