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

Model Number 401701-501

Device Problems Insufficient Cooling (1130); Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The engineering manager at the user facility conducted testing of the cool-cap system.In this testing it was determined that the water was correctly reaching set temperature and the screen would properly respond to commands.The most recent annual maintenance was conducted 8 months prior to the event, during which it was reported that the cooling unit's fans were blocked by accumulated dust.Natus technical service asked for additional details regarding the patient, the patient's condition, specifics of the reported temperature changes, and responsiveness of the touchscreen when the problem occurred, but no response was received.Natus technical service advised that they could not recommend any field repairs and the system must be returned to natus for repair.The system was not returned despite multiple requests sent by natus technical service.

Event Description

It was reported to natus by an engineering manager at the user facility that the temperature of a cool-cap system was changing constantly and no alarm would indicate when these temperature changes would occur.The engineering manager stated that nurses at the user facility claimed that the cool-cap system would restart several times during treatment.The nurses claimed that after one of these restarts the cap could no longer be cooled, the water level in the cap was low, and a patient's temperature rose.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: 7750161
• MDR Text Key: 116055506
• Report Number: 3018859-2018-00137
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 401701-501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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