BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMINGTON MEDICAL

    MDR report key: 9319570 · Received November 13, 2019

    Report

    Report Number
    1056553-2019-00002
    Event Type
    Injury
    Date Received
    November 13, 2019
    Report Date
    October 21, 2019
    Manufacturer
    REMINGTON MEDICAL
    Product Code
    DSA
    PMA / PMN Number
    K971968
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DHR FOR THIS LOT OF PRODUCT IDENTIFIED NO ISSUES WITH PRODUCT QUALITY. ALL PRODUCT WAS 100% INSPECTED FOR FUNCTIONALITY. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER THE DEVICE DID NOT MAINTAIN A SECURE CONNECTION. THE DEFECTIVE DEVICE FROM LOT 1907911 HAS BEEN REQUESTED FOR RETURN FROM THE CUSTOMER TO COMPLETE THE INVESTIGATION.

    Description of Event or Problem · 1

    THE DIRECTOR OF PURCHASING REPORTED TO REMINGTON MEDICAL ON (B)(6) 2019 A COMPROMISED GREY CLIP ON THE ADAP-2000. PER THE STAFF USING THE PRODUCT, II WAS A FAILURE OF THE CLIP (PACE LOC) NOT HOLDING THE (+) AND (-) CONNECTORS SECURELY WHICH RESULTED IN A LOOSE CONNECTION AND THE PATIENT ARRESTED DURING INSTALLATION OF TEMPORARY PACING CABLE. CPR WAS PERFORMED! THE PATIENT LATER HAD A PERMANENT PACEMAKER PLACED AND WAS RELEASED FROM THE HOSPITAL 48 HOURS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112343 REMINGTON MEDICAL DISPOSABLE ADAPTER DSA REMINGTON MEDICAL 1907911

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention