BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBILE CART CAMERA

    MDR report key: 9805143 · Received March 9, 2020

    Report

    Report Number
    9612330-2020-00003
    Event Type
    Malfunction
    Date Received
    March 9, 2020
    Report Date
    September 4, 2020
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    FTT
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE 07TH MAY 2020: INVESTIGATION RESULTS & FINDINGS (NATUS COMPLAINT REF. # 1-702493582). RISK REVIEW: PER DOC-010378 - EEG/PSG RISK ANALYSIS, HAZARD ID - 6.4 IDENTIFIES "SYSTEM CART OR PERIPHERALS FALL OR TIP ONTO PATIENT OR USER WHEN CART IS IDLE, IN MOTION, OR DURING ATTEMPT TO TRAVERSE A THRESHOLD OR OBSTACLE." THE RISK IS CONSIDERED MODERATE. UPON EVALUATION OF THE UNIT, IT WAS NOTED THAT THE MOUNTING TREAD ON BOTH SIDES OF THE CAMERA ARE COMPLETELY DESTROYED WHICH WOULD HAVE BEEN CAUSED BY MISALIGNING THE CAMERA AND POLE WHEN THE CAMERA WAS MOUNTED. THE DESTRUCTION OF THE BOTTOM TREAD SUGGESTS THAT AN ATTEMPT WAS MADE TO MOUNT IT ON THE POLE. THE LACK OF A SECURE, RIDGED ASSEMBLY BETWEEN THE CAMERA AND CARTS POLE COULD RESULT IN THE CAMERA FALLING OFF THE CART. A REPLACEMENT UNIT HAS BEEN SENT TO THE CUSTOMER. THE COMPLAINT AS REPORTED WAS VERIFIED. THIS HAS BEEN DEEMED AN ISOLATED INCIDENT AND WILL CONTINUE TO BE MONITORED FOR FUTURE OCCURRENCE.

    Additional Manufacturer Narrative · 0

    UPDATE 09TH APRIL 2020 MANUFACTURERS INTERNAL REPORT REF. # (B)(4). INVESTIGATION RESULTS & FINDINGS THE SUSPECT DEVICE HAS BEEN RETURNED FOR EVALUATION. INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 0

    MOBILE CART CAMERA FELL ON THE EEG TECHNICIAN HEAD.

    Description of Event or Problem · 0

    MOBILE CART CAMERA FELL ON THE EEG TECHNICIAN HEAD.

    Additional Manufacturer Narrative · 1

    MOBILE CART CAMERA HAS FALLEN ON THE EEG TECHNICIAN HEAD.

    Description of Event or Problem · 1

    MOBILE CART CAMERA FELL ON THE EEG TECHNICIAN HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272697 MOBILE CART CAMERA MOBILE CART CAMERA FTT NATUS MEDICAL INCORPORATED 10295

    Patients

    Seq Age Sex Outcome Treatment
    1