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

Model Number NT821731C

Device Problem Crack (1135)

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

Event Date 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

Initial report ref to natus complaint (b)(4).Part nt821731c customer notified natus of failure with drainage bag.Customer noted the device was in contact with the customer but no delay in surgery or patient injury.Customer states the natus hub is cracked.Per (b)(4) rev 04 - risk analysis spreadsheet eds 3 external drainage system, hazard id line 4.13, severity - 11, acceptable risk.

Event Description

Customer notified natus of failure with drainage bag.No delay in surgery or patient injury.

Manufacturer Narrative

Follow up report 001 ref to natus complaint #(b)(4).Depot repair could not confirm the failure as product will not be returned by the customer.A review of the device history record found no anomalies or non-conformances, the product met specifications upon release.Per doc-035405 rev 04 - risk analysis spreadsheet eds 3 external drainage system, hazard id line 4.13, severity - 11, acceptable risk.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.Capa005047 has been generated to investigate the trend identified with the drainage bag breakage.Investigation result code: san diego|eds products|no return of device for evaluation complaint could not be verified, materials not returned for analysis.Low safety risk of harm, individual complaint related to issue stated.No patient injuries.

Event Description

Customer notified natus of failure with drainage bag.No delay in surgery or patient injury.

• 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 CA
• MDR Report Key: 11307349
• MDR Text Key: 252000933
• Report Number: 2023988-2021-00004
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NT821731C
• Device Catalogue Number: NT821731C
• Device Lot Number: 118000422303
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1