BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IP PTZ ERGOJUST VIDEO EXTENSION

    MDR report key: 18533283 · Received January 18, 2024

    Report

    Report Number
    9612330-2024-00006
    Event Type
    Malfunction
    Date Received
    January 18, 2024
    Date of Event
    January 2, 2024
    Report Date
    January 18, 2024
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    OMB
    UDI-DI
    00382830058377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT (B)(4). TECHNOLOGIST WAS ROLLING THE MACHINE DOWN THE HALLWAY AND NOTICED AN EXTREME TILT OF THE CAMERA TOWER. SHE BROUGHT IT BACK TO THE LAB WHERE THEY INVESTIGATED THE TOWER TO FIGURE OUT WHY IT WAS LEANING. THEY THEN OBSERVED CRACKS AT THE BASE OF THE TOWER. THE REMAINING QTY OF EQUIPMENT WAS EXAMINED AND IT WAS NOTED CRACKS IN 6 OF 7 MACHINES PURCHASED BETWEEN 2021-2022. DOC (B)(6) REV 69 XLTEK EEG PSG RISK ANALYSIS SPREADSHEET IDENTIFIES HAZARD 6.11 - DUE TO MECHANICAL STRESS OR IMPACT, DYNAMIC LOADING, VIBRATION, OR ENVIRONMENTAL CONDITIONS -- ACCESSORY SHELF ON CART MAY BE UNABLE TO SUPPORT THE MASS OF ACCESSORIES OR ITEMS PLACED ON ITS SURFACE, CAUSING IT TO BEND OR BREAK AND LEAVE SHARP EDGES EXPOSED OR BROKEN SUPPORT SYSTEM COULD LAND ON AND HARM SOMEONE. EFFECT (HARM): RANGE FROM CLINICALLY INSIGNIFICANT TO IRREVERSIBLE INJURY RESULTING FROM DIRECT PHYSICAL INJURY. THE HAZARDS IDENTIFIED HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH A KNOWN STANDARD. AS NOTED IN QMS-000018, HAZARDS THAT HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH KNOWN STANDARDS CAN BE PRESUMED TO BE CONSISTENT WITH AN ACCEPTABLE LEVEL OF RISK, YIELDING AN ACCEPTABLE RISK / BENEFIT TO THE PATIENT OR USER. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE. INSTALL DATE: 27-JUN-2021 PN 024779 -ERGOJUST BRACKET KITS WERE SENT TO THE CUSTOMER. THIS KIT APPLIED TO THE CART WILL STOP THE VIDEO EXTENSION FROM FALLING OVER. FIELD SERVICE HAVE INSTALLED THE BRACKETS ON ALL OF THE CARTS, ALL CARTS ARE NOW BACK IN USE. FAILURE CONFIRMED: YES RESOLUTION: SENDING OF ERGOJUST BRACKET KITS RESOLUTION CODE: PREVENTATIVE MAINTENANCE CUSTOMER SYMPTOM CODE: BROKEN/DAMAGED PART INVESTIGATION CASE CLOSED JANUARY 17, 2024.

    Description of Event or Problem · 0

    IP PTZ ERGOJUST VIDEO EXTENSION -VIDEO EXTENSIONS ON 6 OF 7 CART PURCHASED IN 2021 HAVE CRACKS. CAMERA ARMS ARE BREAKING OFF. NO INJURIES. EVENT: 3/6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852752 IP PTZ ERGOJUST VIDEO EXTENSION IP PTZ ERGOJUST VIDEO EXTENSION OMB NATUS MEDICAL INCORPORATED IP-EC-VIDEO-EXT 00382830058377

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown