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

Model Number 401701-501

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 asc representative indicated that there was no fault with the unit and required assistance on how to move forward with the situation.Technical service advised that if there was no issue confirmed, that the unit can be returned to the customer.

Event Description

The event involves a cool-cap unit with a water leak.It was reported that the issue did not involve a death or serious injury that required treatment, a delay in treatment, and an environmental or safety concerns.A representative from an authorized service center (asc), paragon, contacted natus technical service concerning a cool cap system.The customer is alleging that there is a water leak and has reported to have spent approximately 60 hours testing the water circulation.The customer reported that, when filling the bag with water, the cap of the unit was filling well.The remaining water in the bag was leaking onto the floor of the main unit after completely filling the cap.The customer requested that the asc attempt this process to confirm the issue.

• Brand Name: OLYMPIC COOL-CAP
• Type of Device: COOL-CAP
• Manufacturer (Section D): NATUS MEDICAL INC.; 5900 first avenue south; seattle WA 98108
• Manufacturer (Section G): NATUS MEDICAL INCORPORATED; 5900 first avenue south; seattle WA 98108
• Manufacturer Contact: ana szucs ; 5900 first avenue south; seattle, WA 98108 ; 2062685133
• MDR Report Key: 7277196
• MDR Text Key: 100511945
• Report Number: 3018859-2018-00098
• Device Sequence Number: 1
• Product Code: MXM
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: Other
• Type of Report: Initial
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 401701-501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other