BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NV 2.X ARM

    MDR report key: 17332599 · Received July 17, 2023

    Report

    Report Number
    9612330-2023-00019
    Event Type
    Malfunction
    Date Received
    July 17, 2023
    Date of Event
    July 12, 2023
    Report Date
    September 12, 2023
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    FWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF NATUS COMPLAINT# (B)(4). SECTION D4. UDI NUMBER, SERIAL NUMBER IS NOT APPLICABLE. 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. THE CUSTOMER DESTROYED THE CAMERA AND ARM, THEREFORE THEY WILL NOT BE RETURNED. THE FAILURE WAS NOT CONFIRMED. RELATED CAPA NUMBER: (B)(4). CLOSURE RATIONALE: COMPLAINT VERIFIED, CAPA INIATED OR ALREADY OPEN. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT#: (B)(4). SECTION D4. UDI NUMBER, SERIAL NUMBER IS NOT APPLICABLE. THE CUSTOMER DESTROYED THE CAMERA AND ARM, THEREFORE THEY WILL NOT BE RETURNED, THE IFU STATES THAT THE CAMERA SHOULDN'T BE POSITIONED OVER THE BED OR BABY. CAPA005355 ADDRESSES THE DEFICIENCY OF THE ARM. PER DOC-023354, HAZARD I.D. 6.6, SEVERITY 11-CRITICAL, RISK LEVEL-MODERATE.

    Description of Event or Problem · 0

    NV 2.X ARM - ARM BECAME LOOSE. THE CUSTOMER REPORTED "THE ARM BECAME LOOSE AND DROOPED, CAMERA JUST ABOUT HIT BABY IN BED." NO HARM TO PATIENT OR USER.

    Description of Event or Problem · 0

    NV 2.X ARM - ARM BECAME LOOSE. THE CUSTOMER REPORTED "THE ARM BECAME LOOSE AND DROOPED, CAMERA JUST ABOUT HIT BABY IN BED." NO HARM TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488489 NV 2.X ARM NV 2.X ARM FWC NATUS MEDICAL INCORPORATED NVARM

    Patients

    Seq Age Sex Outcome Treatment
    1 0 MO Unknown Other