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

Model Number NT821731C

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 02/21/2021

Event Type  malfunction  

Manufacturer Narrative

Initial report ref to natus complaint (b)(4).Customer confirmed that the failure occurred during placement of the evd.After placement the staff could not get a wave form.Crack was noted when unit was sprayed with saline from the csf port.Additional intervention required as staff had to change out the device to continue with the treatment.The product was requested to be returned for evaluation on february 23rd, march 2nd and march 15th.No response todate.Risk management file review: acceptable risk associated with the complaint as per line 3.11 in (b)(4) rev 04 risk analysis spreadsheet.

Event Description

Eds 3 drain that was leaking from the tubing when they went to flush it.No patient injury or death.

Event Description

Eds 3 drain that was leaking from the tubing when they went to flush it.No patient injury or death.

Manufacturer Narrative

Follow up report 002 (ref to natus complaint #: (b)(4)) product was asked to be returned on february 23rd, march 2nd, march 15th and march 30th 2021.No returns to date.

Event Description

Eds 3 drain that was leaking from the tubing when they went to flush it.No patient injury or death.

Manufacturer Narrative

Follow up report (ref to natus complaint #(b)(4)).19 mar 2021: additional communication with the customer shows that the customer has thrown away the box so unable to confirm any additional information with the part at the moment.Product is still at the facility - technical service has requested to have a picture sent of the product or to be returned to cg labs.30 mar 2021: additional attempt made to confirm if product will be returned.

Manufacturer Narrative

Follow up report (b)(4).Ref to natus complaint #(b)(4).Product examination and functional testing: product was evaluated and confirmed there is a crack in the product producing a leak.Per update provided by engineering: "there is a crack in the y fitting that allows sampling of the csf before the csf reaches the burette.There is a small crack visible along the length of the plastic part, approximately 0.3" long.There are no defects observed in the flexible tubing.Injecting water into the tubing showed a leak from the crack in the fitting.Lot/serial numbers:(b)(6).Manufacturing dates: 25-may-2021; 13-may-2021;13-may-2021.Capa trending review: capa005047 has already been issued to investigate the root cause of the failure.Risk management file review: acceptable risk associated with the complaint as per line 3.11 in (b)(4) rev 04 risk analysis spreadsheet.Investigation result code: san diego|eds products|leakage complaint will be included in trending data for further review and investigation if needed.

Event Description

Eds 3 drain that was leaking from the tubing when they went to flush it.No patient injury or death.

• 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, 92121 CA
• MDR Report Key: 11496835
• MDR Text Key: 245523644
• Report Number: 2023988-2021-00005
• 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,Followup,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/23/2021
• Initial Date FDA Received: 03/16/2021
• Supplement Dates Manufacturer Received: 02/23/2021; 02/23/2021; 02/23/2021
• Supplement Dates FDA Received: 04/14/2021; 05/13/2021; 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1