BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SEDI-40

    MDR report key: 13792286 · Received March 17, 2022

    Report

    Report Number
    2243072-2022-00362
    Event Type
    Malfunction
    Date Received
    March 17, 2022
    Date of Event
    March 7, 2022
    Report Date
    June 23, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    K953994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN THIS MDR, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AS (B)(4) IS AN OEM MANUFACTURING SITE. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. 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.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: INSTRUMENT SEDI 40 19-42033 WAS RETURNED TO THE MANUFACTURER FOR SERVICE WITH RESPECT TO THE REPORTED DEFECT ¿ DAMAGED POWER SUPPLY. THE INSTRUMENT WAS EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING AND IT WAS FOUND THAT POWER SUPPLY PCB WAS DEFECTIVE. THE POWER SUPPLY PCB WAS REPLACED. AFTER REPAIR THE INSTRUMENT PASSED ALL FURTHER QUALITY CHECKS. THIS COMPLAINT HAS BEEN CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD SEDI-40 THERE WAS A BROKEN/DAMAGED INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE POWER SUPPLY INLET WAS DESTROYED."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD SEDI-40 THERE WAS A BROKEN/DAMAGED INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE POWER SUPPLY INLET WAS DESTROYED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246288 BD SEDI-40 ESR INSTRUMENT JKA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown