BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NV 2.X ARM

    MDR report key: 16917810 · Received May 12, 2023

    Report

    Report Number
    9612330-2023-00007
    Event Type
    Malfunction
    Date Received
    May 12, 2023
    Date of Event
    April 28, 2023
    Report Date
    June 13, 2023
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    FWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF NATUS COMPLAINT #(B)(4). THE CUSTOMER RETURNED THE DEFECTIVE DEVICE TO NATUS, AND PROVIDED PICTURES OF THE DEFECTIVE DEVICES. INVESTIGATION RESULTS: THIS ARM IS EXHIBITING THE SAME TYPE OF "DROOPING" ISSUE THAT WE HAVE SEEN IN THE PAST ON THESE ARMS. OVER TIME THE ARM CAN LOSE ITS ABILITY TO HOLD A WORST CASE HORIZONTAL POSITION BUT CAN STILL BE POSITIONED TO BE FUNCTIONAL. IN THIS CASE THE ARM WAS BUMPED AND AS A RESULT MOVED. THE USERS ARE INFORMED TO NEVER POSITION THE ARM OVER A BED. A POST MARKET RISK ASSESSMENT WAS PERFORMED (DOC-(B)(4)) AND NO ACTION IS REQUIRED. A PICTURE SHOWS OF THE RESTING POSITION OF THE ARM THAT WAS RETURNED AFTER STARTING IN A HORIZONTAL POSITION. DAMAGE TO THE CAMERA WAS ALSO OBSERVED INDICATING THE CAMERA DIRECTION AT THE BALL HEAD WAS ADJUSTED IMPROPERLY BY ADJUSTING THE POSITION OF THE CAMERA WITHOUT FIRST LOOSENING THE BALL HEAD. A PICTURE SHOWS THE AMOUNT OF ARM DROOPED AFTER POSITIONING THE CAMERA IN A HORIZONTAL POSITION AND A PICTURE SHOWS THE MOUNTING NUT INSIDE THE CAMERA BENT OUT OF POSITION. ROOT CAUSE/PROBABLE ROOT CAUSE: KNOWN ISSUE, WEAR OR LOSS OF RIGIDITY OVER TIME. EXTERNAL FORCE OF BUMPING THE ARM CAUSED IT TO MOVE. RECOMMENDED ACTIONS: NO ACTION, ARM IS PHASE-OUT AND BEING REPLACED BY NVARM2. FAILLURE CONFIRMED: YES. 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. THERE ARE NO CAPA'S RELATED TO THIS ISSUE. THIS COMPLAINT DOES NOT IDENTIFY A DEFICIENCY IN THE PRODUCT DESIGN AND THEREFORE A CAPA IS NOT REQUIRED. PER (B)(4), COMPLAINT HISTORIES ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS AND ANY COMPLAINT TRENDS ARE ASSESSED AND DOCUMENTED AS PART OF THESE REVIEWS. PER (B)(4), HAZARD I.D. 6.6, SEVERITY 11-CRITICAL, RISK LEVEL-MODERATE. A RISK REVIEW IS NOT REQUIRED AS THIS COMPLAINT DOES NOT DESCRIBE A NEW FAILURE MODE OR NEW HARM AND THE EXISTING HAZARD SEVERITY AND/OR PROBABILITY OF OCCURRENCE HAS NOT CHANGED. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Description of Event or Problem · 0

    PART NVARM: THE ENTIRE ARM OF THE CAMERA, WITH CAMERA ATTACHED SWUNG AND HIT THE INFANT ON THE SIDE OF THE HEAD AFTER BEING BUMPED WHILE MOM WAS HOLDING BABY FOR A BED CHANGE. THE PATIENT DID NOT REQUIRE FURTHER HOSPITALIZATION. THE AFFECT PART TO BE RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 0

    PART NVARM - THE ENTIRE ARM OF THE CAMERA, WITH CAMERA ATTACHED SWUNG AND HIT THE INFANT ON THE SIDE OF THE HEAD AFTER BEING BUMPED WHILE MOM WAS HOLDING BABY FOR A BED CHANGE. THE PATIENT DID NOT REQUIRE FURTHER HOSPITALIZATION. THE AFFECT PART TO BE RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1652695 NV 2.X ARM NV 2.X ARM FWC NATUS MEDICAL INCORPORATED NVARM

    Patients

    Seq Age Sex Outcome Treatment
    1 0 MO Female