MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED IP-EC-VIDEO-EXT

Model Number IP-EC-VIDEO-EXT

Device Problem Crack (1135)

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

Event Date 09/12/2023

Event Type  malfunction  

Manufacturer Narrative

Initial report ref natus complaint# (b)(4).There are no capa's related to this issue.This complaint does not identify a deficiency in the product design and therefore a capa is not required.Per (b)(4), complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.Per (b)(4) xltek eeg psg risk analysis, hazard id 6.11, severity 11-critical, risk level-moderate.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.Further investigation to be carried out.

Event Description

Ip ptz ergojust video extension: arm to camera has broken.The customer said that this actually happened while the technician was pushing it down the hallway.No one was hurt or injured during the event.He stated he noticed it falling down and caught it and held it up until he got back into the department.The customer provided pictures of the device.

Event Description

Ip ptz ergojust video extension: arm to camera has broken.The customer said that this actually happened while the technician was pushing it down the hallway.No one was hurt or injured during the event.He stated he noticed it falling down and caught it and held it up until he got back into the department.The customer provided pictures of the device.

Manufacturer Narrative

Follow up report 002 ref natus complaint# (b)(4).Several follow up attempts were made to the customer, requesting them to return the affected device for evaluation.18-dec-2023: it has been 45 days since the last subsequence follow up, the customer hasn't returned the device for evaluation.Faillure confirmed: no investigation result code: neuro sbu|product not returned this complaint will be included in trending data for further review.

Event Description

Ip ptz ergojust video extension: arm to camera has broken.The customer said that this actually happened while the technician was pushing it down the hallway.No one was hurt or injured during the event.He stated he noticed it falling down and caught it and held it up until he got back into the department.The customer provided pictures of the device.

Manufacturer Narrative

Follow up report 001 ref natus complaint# (b)(4).A device history record review is not applicable because, prior to the reported issue the device was in service for 2 or more years and a manufacturing defect is very unlikely.Install date of device: 9-oct-2020.Manufacturing date: 02-mar-2020.Awaiting further feedback from the customer, with reference to return of the affected device.Further investigation to be carried out.

• Brand Name: IP-EC-VIDEO-EXT
• Type of Device: IP-EC-VIDEO-EXT
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; dba excel-tech ltd.; 2568 bristol circle; oakville, ontarios, l6h 5s1, ; CA
• 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 5s1, ; CA
• MDR Report Key: 17877524
• MDR Text Key: 325006775
• Report Number: 9612330-2023-00036
• 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,Followup,Followup
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1