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

Model Number 401701-501

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The cool cap is currently in the process of returning to the asc for further evaluation.

Event Description

The event involves a cool-cap unit with an e90 filling error.There has been no report of 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) contacted natus technical service concerning a cool cap with a filling error (e90).The customer reported that the pump had some faults and that the internal filter was cleaned prior to testing, but the filling error message was still present.

• 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: 7277192
• MDR Text Key: 100510959
• Report Number: 3018859-2018-00102
• 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: 01/18/2018

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: 01/18/2018
• 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