BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRED SECURITY CAMERA (WEB ENABLED) - CLAMP-004 TABLE MOUNT

    MDR report key: 14496438 · Received May 25, 2022

    Report

    Report Number
    9612330-2022-00030
    Event Type
    Malfunction
    Date Received
    May 25, 2022
    Date of Event
    April 26, 2022
    Report Date
    June 20, 2022
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    FWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT# (B)(4). THE CUSTOMER REPORTED TO NATUS THAT A NICVIEW CAMERA FELL AT BEDSPOT 6 OFF OF THE WALL. THEY SAID THERE WAS NO HARM WAS DONE TO PATIENT. THEY CONCERNED IF THE INCIDENT KEEPS OCCURRING, THEY WILL HAVE AN INFANT INJURED. THEY WERE HOLDING THE CAMERA IN THEIR OFFICE AND PROVIDED IMAGES FROM WHERE IT BROKE OFF. THEY MENTIONED THIS IS AT LEAST THE 5TH TIME IN THE PAST YEAR THIS HAS OCCURRED WITH THIS BRACKET, AND REQUESTED MORE SPARE PARTS SINCE THEY RAN OUT OF THEM. TECHNICAL SERVICE NOTED THAT THEY PROVIDED THE USER WITH A REPLACEMENT FORM (TWICE) BUT HAVE RECEIVED NO RESPONSE FROM THE CUSTOMER. THE TS SAID THAT THE CUSTOMER DID NOT WANT TO REPLACE THE CAMERA, AND ADVISED THAT GIVEN THE SITUATION WE WOULD NEED THE CAMERA AND PROVIDED ANOTHER REPLACEMENT FORM. PRODUCT RETURN WAS NOT REQUESTED FOR THE EVALUATION. THE PICTURES OF THE DAMAGED DEVICE WERE PROVIDED BY THE CUSTOMER. 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. UDI#: NOT APPLICABLE. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF NATUS COMPLAINT# (B)(4) (COMPLAINT# (B)(4) WAS REFERENCED IN ERROR IN THE INITIAL REPORT) PRODUCT RETURN WAS NOT REQUESTED FOR THE EVALUATION. PICTURES OF THE DAMAGED DEVICE WERE PROVIDED BY THE CUSTOMER. 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 PER (B)(4) DOES NOT HAVE A CORRESPONDING RISK IDENTIFIER; HOWEVER, PER (B)(4), REV.B, SEVERITY SCORE OF 1-NEGLIGIBLE AND RISK LEVEL IS LOW. 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. SERIAL NUMBER WAS NOT PROVIDED. FAILLURE CONFIRMED:YES CLOSURE RATIONALE: LOW SAFETY RISK OF HARM, INDIVIDUAL COMPLAINT RELATED TO ISSUE STATED. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW AND INVESTIGATION IF NEEDED. NO DEATH OR SERIOUS INJURY, CONSIDERED A CUSTOMER INCONVENIENCE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A NICVIEW CAMERA FELL AT BEDSPOT 6 OFF OF THE WALL. THEY SAID THERE WAS NO HARM DONE TO THE PATIENT. THEY ARE CONCERNED IF THE INCIDENT KEEPS OCCURRING, IT COULD CAUSE AN INJURY. ( PART CLAMP-004 TABLE MOUNT).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A NICVIEW CAMERA FELL AT BEDSPOT 6 OFF OF THE WALL. THEY SAID THERE WAS NO HARM DONE TO THE PATIENT. THEY ARE CONCERNED IF THE INCIDENT KEEPS OCCURRING, IT COULD CAUSE AN INJURY. ( PART CLAMP-004 TABLE MOUNT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2806832 WIRED SECURITY CAMERA (WEB ENABLED) - CLAMP-004 TABLE MOUNT FWC NATUS MEDICAL INCORPORATED CLAMP-004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown