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

Model Number DM401352-503

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Natus technical service followed up with a biomedical technician (biomed) at the user facility to obtain further details concerning the leaking system.The biomed confirmed that there was a cracked o-ring on the out line connector of the main hose.A replacement main hose assembly was sent to the user facility, and the biomed confirmed that the cool-cap system was working well with the replacement main hose assembly installed.The main hose assembly involved in the complaint was returned to natus and evaluated by natus factory service.The hose assembly was installed on a cool-cap troubleshooting fixture and water leaked at the hose assembly's connector mated to the "main hose out" of the cool-cap base.

Event Description

It was reported to natus that a cool-cap system developed a slow water leak at the water fittings on the back of the cooling tower at the beginning of treatment.The complainant stated that they continued to use the system for 36 hours before transitioning the patient to a second cool-cap loaner system which was being used at the time.There were no alarms that prompted or any problems reported during the treatment.There was no report of death, serious injury, or environmental/safety concerns.

• Brand Name: OLYMPIC COOL-CAP
• Type of Device: COOL-CAP
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 5900 first avenue south; seattle WA 98108
• Manufacturer (Section G): NATUS MEDICAL INCORPORATED; 5900 first avenue south; seattle WA 98108
• Manufacturer Contact: james fitzgerald ; 5900 first avenue south; seattle, WA 98108 ; 2062685173
• MDR Report Key: 7737021
• MDR Text Key: 115650261
• Report Number: 3018859-2018-00134
• Device Sequence Number: 1
• Product Code: MXM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DM401352-503
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other