MAUDE Adverse Event Report: NATUS MEDICAL INC. OLYMPIC COOL-CAP

Model Number 401352-01

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the patient was placed into a backup cooling device.The customer has not reported the alarm identifier, the patient's rectal temperature or the specific hours of treatment.Follow up communication attempts with the customer were carried out on 14 dec 2017 and 09 jan 2018.These follow up attempts have been unsuccessful in obtaining additional information thus far.The customer has since placed an order for device service and a loaner cool cap unit.

Event Description

A customer called natus technical service to report that, prior to the call, the cool cap device was indicating that there was a major water leak and the patient had been cooling for two days.The customer confirmed that there was no apparent water leakage, but the main hose (red) was reported not to be completely connected.The customer also reported a full water bag.After properly connecting the main hose, the issue still persisted, and the customer was unable to clear the error.The cool cap was rebooted, and during the reboot process, the customer reported that the system would not fill and that the resume selection was "grayed out." the customer attempted to replace/spike a new bag.The customer also reported that the area was loud, which would not allow them to verify if the pump was active or if the system made any clicking noises.No death, serious injury, delay in care or environmental/safety concerns have been reported.

Manufacturer Narrative

The suspected cool-cap unit sn#(b)(6) was returned back to natus on (b)(6) 2018 for repair, natus factory service did the repair and noted "unable to confirm complaint of "major water leak" error.Unit passed cool cap full ftp doc-001692 n".On (b)(6) 2018) the unit was sent to customer and natus technical service made follow up attempts on (b)(6) 2018 & (b)(6) 2018) to get an update on the unit, no response was received from customer.

• Brand Name: OLYMPIC COOL-CAP
• Type of Device: COOL-CAP
• Manufacturer (Section D): NATUS MEDICAL INC.; 5900 first avenue south; seattle WA 98108
• MDR Report Key: 7179627
• MDR Text Key: 96966653
• Report Number: 3018859-2018-00030
• 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
• Source Type: user facility
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 401352-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other