MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED IP PTZ ERGOJUST VIDEO EXTENSION

Model Number	IP-EC-VIDEO-EXT
Medical Device Problem Codes	Crack (1135); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 (b)(4) machines purchased between 2021-2022.Doc-(b)(4) 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-(b)(4), 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: (b)(6) 2021.Pn (b)(6) -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.
Event or Problem Description
Ip ptz ergojust video extension -video extensions on (b)(4) cart purchased in 2021 have cracks.Camera arms are breaking off.No injuries.Event: 2/6.

• Brand Name: IP PTZ ERGOJUST VIDEO EXTENSION
• Common Device Name: IP PTZ ERGOJUST VIDEO EXTENSION
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; dba excel-tech ltd.; 2568 bristol circle; oakville, ontarios, L6H 5 S1; CA L6H 5S1
• Manufacturer (Section G): NATUS MANUFACTURING LIMITED; ida business park; gort; galway h91pd92, ; EI
• Manufacturer Contact: gráinne walsh ; dba excel-tech ltd.; 2568 bristol circle; oakville, ontarios, L6H 5-S1 ; CA L6H 5S1
• MDR Report Key: 18533279
• Report Number: 9612330-2024-00005
• Device Sequence Number: 17837371
• Product Code: OMB
• UDI-Device Identifier: 00382830058377
• UDI-Public: 00382830058377
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IP-EC-VIDEO-EXT
• Device Catalogue Number: IP-EC-VIDEO-EXT
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown