MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED OLYMPIC COOL-CAP

Model Number 005094

Device Problem Insufficient Cooling (1130)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Natus technical service has requested return of the system.Natus technical service has sent questions to the complainant regarding the details of the event and the patient involved in the event.A response to these requests has not been received.

Event Description

It was reported that a cool-cap system's cap temperature was high as compared to the set temperature.A patient was being treated with the system when the event occurred, and the patient was moved to another cool-cap system.There was no death, serious injury, delay in treatment, or environmental/safety concerns.A service technician who reported the event performed a heat load test as described in the cool-cap service manual and functional test procedure.The technician claimed that the test demonstrated that the internal thermistors were faulty.However, based on photos provided by the technician, natus factory service noted that the heat load test was performed incorrectly.Natus factory service stated that testing the functionality of the cooling modules would also require performing a different test.

Manufacturer Narrative

Natus technical service has requested return of the system, the unit was received by natus for repair on 10/23/2018.Natus factory service confirmed customer complaint and found a faulty cooling module on b side of cooling block.Thus, only one side of the cooling block was functioning, this was the root cause of the issue.Both cooling modules inside cooling block were replaced and the problem was fixed.Cd drive was also found to have tray issue and was replaced.Unit was fixed and passed cool cap ftp doc-001692 rev.O.The unit was sent to customer on 11/08/2018 and natus technical service made follow up with customer to check the status of the device.Customer confirmed that the equipment has been successfully installed with no issues.

• Brand Name: OLYMPIC COOL-CAP
• Type of Device: COOL-CAP
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 5900 first avenue south; seattle WA 98108
• MDR Report Key: 7873604
• MDR Text Key: 120256986
• Report Number: 3018859-2018-00150
• Device Sequence Number: 1
• Product Code: MXM
• Combination Product (y/n): N
• PMA/PMN Number: P040025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 005094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Date Manufacturer Received: 10/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other