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

Device Problems Filling Problem (1233); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The reported e97 sensor failure alarm describes a malfunction.Although there has been no report of patient/user death or serious injury, this malfunction has the risk of causing serious injury under specific circumstances if it were to recur.Natus technical service made multiple follow up attempts to obtain further details regarding product functionality and patient status at time of event alarms.If additional information becomes available natus will file a follow up report.

Event Description

Customer contacted natus technical service to report that their cool-cap device displayed a e97 system sensor failure alarm error.Natus technical support followed up with the customer and confirmed that there was a delay in treatment caused by the malfunction.Tsr provided customer the troubleshooting instructions and informed customer that the device may be returned to natus for repair.Natus technical support made multiple follow ups to obtain more information on product functionality and patient status at time of event.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 INC.; 5900 first avenue south; seattle WA 98108
• Manufacturer (Section G): NATUS MEDICAL INC.; 5900 first avenue south; seattle WA 98108
• Manufacturer Contact: james fitzgerald ; 5900 first avenue south; seattle, WA 98108 ; 2062685173
• MDR Report Key: 8574865
• MDR Text Key: 161279255
• Report Number: 3018859-2019-00004
• Device Sequence Number: 1
• Product Code: MXM
• Combination Product (y/n): N
• PMA/PMN Number: P040025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2019
• 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