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

Device Problem Insufficient Cooling (1130)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The asc used certified calibrated instruments, and it was determined that the temperature sensors work correctly.At the same time, a flow thermometer was used to verify the temperature of the water flow.The asc found that the machine is not able to get to the temperature of 15°c.The asc performed testing per natus service manual instructions.The asc believes the cooling unit has failed and has contacted technical service for repair options.An email requesting more information was sent to the customer on 5/25/2018, and the customer has not responded.

Event Description

An end user reported to the authorized service center (asc) that the cool cap temperature readings were suspected to be incorrect.There has been no report of a death or serious injury that required treatment, a delay in treatment, and an environmental or safety concerns.

• 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: jim fitzgerald ; 5900 first avenue south; seattle, WA 98108 ; 2062685173
• MDR Report Key: 7562963
• MDR Text Key: 110365242
• Report Number: 3018859-2018-00131
• Device Sequence Number: 1
• Product Code: MXM
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2018
• 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