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

Model Number 401350-503

Device Problem Insufficient Cooling (1130)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2018

Event Type  malfunction  

Event Description

Natus received a report that the cap temperature reported by a cool-cap device was higher than the desired set cap temperature and the set cap temperature could not be reached.The device was being used on a patient at the time of the event.Over a period of three hours, the cap temperature was reported to be between 14.3 deg.C and 14.7 deg.C at a set temperature of 13 deg.C, and rectal temperature rose from 34.5 deg.C to 34.8 deg.C.A shift change occurred and the night nurse attending to the patient began troubleshooting.Over a period of approximately two hours, set temperature was decreased to 12.5 deg.C and 12.0 deg.C.Cap temperature rose from 14.3 deg.C to 14.5 deg.C, and rectal temperature rose from 34.9 deg.C to 35.2 deg.C.The device was then swapped out for a backup cool-cap device.(the cool-cap operator's manual states that the cool-cap system is designed to maintain an infant's rectal temperature within a target range of 34.0 deg.C - 35.0 deg.C by adjusting cap temperature.) changing to the backup cool-cap device was reported to have caused a delay of treatment of 15-20 minutes.There was no report of death, serious injury, or environmental/safety concerns.Natus technical service contacted the complainant to obtain additional information.The complainant reported that radiant heat was not reaching the cap, the insulating cap and heat shield were in place, there were no external sources of heat near the heating cap, and the hoses were not kinked.On 02/12/2018, natus technical service advised the complainant and user facility to return the unit for repair.A biomedical technician at the user facility reported results of testing performed on the cool-cap device mentioned in the complaint after the event.The technician ran the device for several hours at 12 deg.C set cap temperature and reported that the device remained at 12 deg.C.In a separate test, when set temperature was set to 10.0 deg.C, the device achieved 10.0 deg.C cap temperature in 37 minutes.When set temperature was then set to 14.0 deg.C, cap temperature reached 13.9 deg.C in 21 minutes.

• 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: kyle horton ; 5900 first avenue south; seattle, WA 98108 ; 2068343921
• MDR Report Key: 7290849
• MDR Text Key: 100911931
• Report Number: 3018859-2018-00103
• Device Sequence Number: 1
• Product Code: MXM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 401350-503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2008
• 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
• Patient Age: 24 HR