BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD ACCESSORIES BATTERY

    MDR report key: 9565742 · Received January 8, 2020

    Report

    Report Number
    3012307300-2020-00094
    Event Type
    Malfunction
    Date Received
    January 8, 2020
    Date of Event
    November 23, 2019
    Report Date
    April 20, 2020
    Manufacturer
    SMITHS MEDICAL ASD,INC
    Product Code
    MRZ
    UDI-DI
    10610586031212
    PMA / PMN Number
    K072144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION ON MDR FILE 3012307300-2020-00093- 0061638 .THIS FILE IS CONSIDERED NON REPORTABLE TO FDA, AS THIS IS A CADD ACCESSORY LITHIUM BATTERY AND NOT AN INTERNAL BATTERY. THIS WOULD BE CONSIDERED PRIOR TO USE ACTION.

    Description of Event or Problem · 0

    CORRECTION BEING MADE ON MDR FILE. SUMMARY IN H 10.

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS IS DONE BY SUPPLIER, WHICH IS ULTRALIFE CORP. SQE: (B)(6).

    Description of Event or Problem · 1

    INFORMATION RECEIVED A SMITHS MEDICAL CADD ASSESSORIES BATTERY WILL ONLY CHARGE AND ACCEPT 75%. BATTERY WAS CHANGED ON (B)(6) 2018. NO PATIENT ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26905 CADD ACCESSORIES BATTERY ACCESSORIES, PUMP, INFUSION MRZ SMITHS MEDICAL ASD,INC BATTERY PACK, RECHARGEABLE, LITHIUM ION, 3.7V, 1400 10610586031212

    Patients

    Seq Age Sex Outcome Treatment
    1