MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED EXT CABLE (FIBEROPTIC CATHETERS TO CAMINO MONITOR)

Model Number CAMCABL

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 10/06/2022

Event Type  malfunction  

Manufacturer Narrative

Initial report ref natus complaint# (b)(4).The affected prouct has been requested to be returned for evaluation.Several attempts were made in requesting that the product would be returned for investigation and several attempts were made to collect the complaint form to confirm if there was patient/user harm.No response from 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) complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.Acceptable risk associated with the complaint as per line 12.2 doc-033950 camino icp monitor risk analysis, severity - 3, low risk.No death or serious injury, considered a customer inconvenience.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 review of complaint details to be carried out before final closure.

Event Description

Part camcabl - temp error.Customer originally made report on their cam02 unit, sn: (b)(4), stating the temperature readings are not correct.Customer was recommended to replace the camcabl, which resolved the issue.Customer was asked to return the complaint form.

Manufacturer Narrative

Follow up report 001.Ref natus complaint# (b)(4).Several attempts were made in requesting that the product would be returned for investigation.02-dec-2022: product was not returned.Unable to evaluate the product.Complaint history was reviewed for the previous two years and found 4 confirmed complaints, giving an incident rate of (b)(4).Device history record was reviewed and no related faults/issue found.Failure confirmed: no.Closure rationale: complaint could not be verified, materials not returned for analysis.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.

Event Description

Part camcabl : temp error.Customer originally made report on their cam02 unit, sn: (b)(6), stating the temperature readings are not correct.Customer was recommended to replace the camcabl, which resolved the issue.Customer was asked to return the complaint form.

• Brand Name: EXT CABLE (FIBEROPTIC CATHETERS TO CAMINO MONITOR)
• Type of Device: EXT CABLE (FIBEROPTIC CATHETERS TO CAMINO MONITOR)
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 5955 pacific center boulevard; san diego, ca 92121 CA
• Manufacturer (Section G): NATUS MANUFACTURING LIMITED; ida business park; gort; galway h91pd92, ; EI
• Manufacturer Contact: gráinne walsh ; 5955 pacific center boulevard; san diego, 92121, CA
• MDR Report Key: 15734373
• MDR Text Key: 307570368
• Report Number: 2023988-2022-00019
• Device Sequence Number: 1
• Product Code: GWM
• UDI-Device Identifier: 10381780039556
• UDI-Public: 00382830048668
• 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
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CAMCABL
• Device Catalogue Number: CAMCABL
• Device Lot Number: JA0321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2020
• 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
• Patient Sex: Prefer Not To Disclose