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

Model Number IP-EC-VIDEO-EXT

Device Problems Crack (1135); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/02/2024

Event Type  malfunction  

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 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.

Event Description

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.

• Brand Name: IP PTZ ERGOJUST VIDEO EXTENSION
• Type of Device: 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: 18533283
• MDR Text Key: 333465901
• Report Number: 9612330-2024-00006
• Device Sequence Number: 1
• Product Code: OMB
• UDI-Device Identifier: 00382830058377
• UDI-Public: 00382830058377
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

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