BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POCKET DOP II

    MDR report key: 9881350 · Received March 25, 2020

    Report

    Report Number
    3010611950-2020-00008
    Event Type
    Malfunction
    Date Received
    March 25, 2020
    Date of Event
    March 5, 2020
    Report Date
    March 25, 2020
    Manufacturer
    NATUS NEUROLOGY INCORPORATED
    Product Code
    JAF
    PMA / PMN Number
    PRE AMENDMEN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE 23RD APRIL 2020: INVESTIGATION RESULTS & FINDINGS (NATUS COMPLAINT REF. # (B)(4)). DHR REVIEW : DHR WAS REVIEWED AND NO RELATED FAULTS/ISSUES FOUND. REFERENCE SPG DHR RELEASE CHECKLIST #KB0009, PN: XPA002, DOCUMENT (NUMBER), ORDER NUMBER: (B)(4). PRODUCT EXAMINATION AND FUNCTIONAL TESING : PRODUCT RECEIVED IN HOUSE AS OF MARCH 17, 2020, CONFIRMED NO ISSUES FOUND WITH THE PROBE, HOWEVER CIRCUIT BOARD WAS REPLACED AND NEW BATTERIES WERE INSTALLED. CAPA TRENDING REVIEW: THERE ARE NO CAPA'S RELATED TO THIS ISSUE AND THIS COMPLAINT DOES NOT IDENTIFY A DEFICIENCY IN THE PRODUCT DESIGN AND THEREFORE A CAPA IS NOT REQUIRED. COMPLAINT TRENDING REVIEW: PER QMS-004442 COMPLAINT HISTORIES ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS AND ANY COMPLAINT TRENDS ARE ASSESSED AND DOCUMENTED AS PART OF THESE REVIEWS. NO COMPLAINT TRENDS HAVE BEEN IDENTIFIED. RISK MANAGEMENT REVIEW FILE : PER DOC-014040 SPG RISK ANALYSIS, HAZARD ID-5.32 IDENTIFIES "EXCESSIVE NOISE IN OB PROBE, UNABLE TO HEAR HEARTBEAT" AS A HAZARD. THE SEVERITY ASSOCIATED WITH THIS HAZARD IS 3 AND THIS IS DEEMED AN UNACCEPTABLE RISK. SERVICE RECORD REVIEW : SERVICE REPAIR INVESTIGATIONS WILL BE CONDUCTED DURING THE REPAIR PROCESS AND TREND DATA WILL BE REVIEWED PER QMS-004442. THIS ISSUE WILL BE CONTINUED TO BE MONITORED.

    Description of Event or Problem · 0

    CUSTOMER'S POCKETDOP II DISPLAYS NO HEART TONES.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION - NO PATIENT INJURY REPORTED, DEVICE MALFUNCTION OCCURRED. DATE OF EVENT - DATE OF EVENT REQUESTED FROM THE CUSTOMER BUT INFORMATION NOT YET PROVIDED RELEVANT TESTS / LABORATORY DATA - THIS SECTION IS NOT APPLICABLE AS NO PATIENT INJURY OCCURRED. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: THIS SECTION IS NOT APPLICABLE AS NO PATIENT INJURY OCCURRED. SUSPECT PRODUCTS - NOT APPLICABLE SERIAL # - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE DOES NOT HAVE A SERIAL NUMBER. IF IMPLANTED DATE (MM/DD/YYYY) - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. IF EXPLANTED DATE (MM/DD/YYYY) - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. REPROCESSOR NAME AND ADDRESS - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT A SINGLE-USE DEVICE THAT WAS REPROCESSED OR REUSED ON A PATIENT. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES (EXCLUDING TREATMENT OF EVENT) - THIS SECTION IS NOT APPLICABLE TO THIS TYPE OF DEVICE. FOR USE BY USER FACILITY / IMPORTER - NOT APPLICABLE AS WE ARE NOT A FACILITY OR IMPORTER OF DEVICE. IF ND, GIVE PROTOCOL # - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IND. ADVERSE EVENT TERMS - THIS SECTION IS NOT APPLICABLE TO MEDICAL DEVICES. IF REMEDIAL ACTION INITIATED , CHECK TYPE - THIS SECTION IS NOT APPLICABLE AS NO REMEDIAL ACTION WAS INITIATED. IF ACTION REPORTED TO FDA UNDER 21 USC 360I (F), LIST CORRECTION / REMOVAL REPORTING NUMBER - THIS SECTION IS NOT APPLICABLE AS THERE WAS NO ACTION REPORTED UNDER 21USC 360I(F).

    Description of Event or Problem · 1

    CUSTOMER'S POCKETDOP II DISPLAYS NO HEART TONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345191 POCKET DOP II POCKET DOP II JAF NATUS NEUROLOGY INCORPORATED XPA002

    Patients

    Seq Age Sex Outcome Treatment
    1