MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED NT821731C, EDS 3, GEN LL, NO CATHETER

Model Number NT821731C

Device Problem Microbial Contamination of Device (2303)

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

Event Date 12/12/2023

Event Type  malfunction  

Manufacturer Narrative

Initial report ref to natus complaint # (b)(4).Lot number of the affected part was not confirmed.The customer was asked to complete the customer complaint form and asked to confirm if product is available to be returned.There are no capa's related to this issue.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.Per doc-035405, hazard id - 3.7, severity - 11, risk - 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.Ref to res# (b)(4) product recall.Further investigation to be carried out.

Event Description

Part nt821731c - customer contacted natus and provided a response to our recall form and confirmed they had affected lots.Customer also mentioned they have patients that may have developed infections from the recalled lots.

Manufacturer Narrative

Follow up report 001 ref to natus complaint # (b)(4).Ref to res# (b)(4) product recall.Customer was asked to complete the customer complaint form and to provide additional details on the alleged event on (b)(6) 2023.Three additional follow ups were also made for this information on (b)(6) 18th and (b)(6) 2024.Customer responded to second request, but asked for a follow up on the recall actions.No completed form was provided.No confirmation received that the customer would return the part.Further investigation to be carried out.

Event Description

Part nt821731c - customer contacted natus and provided a response to our recall form and confirmed they had affected lots.Customer also mentioned they have patients that may have developed infections from the recalled lots.

• Brand Name: NT821731C, EDS 3, GEN LL, NO CATHETER
• Type of Device: NT821731C, EDS 3, GEN LL, NO CATHETER
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 5955 pacific center boulevard; san diego; CA 92121
• Manufacturer (Section G): NATUS MANUFACTURING LIMITED; ida business park; gort; h91pd92, ; EI
• Manufacturer Contact: gráinne walsh ; 5955 pacific center boulevard; san diego, CA 92121
• MDR Report Key: 18424329
• MDR Text Key: 332603190
• Report Number: 2023988-2024-00004
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162437
• 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: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NT821731C
• Device Catalogue Number: NT821731C
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other