OLYMPIC COOL-CAP 401350-503

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-02-22 for OLYMPIC COOL-CAP 401350-503 manufactured by Natus Medical Incorporated.

Event Text Entries

[100911931] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3018859-2018-00103
• MDR Report Key: 7290849
• Report Source: HEALTH PROFESSIONAL,USER FACI
• Date Received: 2018-02-22
• Date of Report: 2018-01-23
• Date of Event: 2018-01-20
• Date Mfgr Received: 2018-01-23
• Device Manufacturer Date: 2008-03-20
• Date Added to Maude: 2018-02-22
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: BIOMEDICAL ENGINEER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: KYLE HORTON
• Manufacturer Street: 5900 FIRST AVENUE SOUTH
• Manufacturer City: SEATTLE WA 98108
• Manufacturer Country: US
• Manufacturer Postal: 98108
• Manufacturer Phone: 2068343921
• Manufacturer G1: NATUS MEDICAL INCORPORATED
• Manufacturer Street: 5900 FIRST AVENUE SOUTH
• Manufacturer City: SEATTLE WA 98108
• Manufacturer Country: US
• Manufacturer Postal Code: 98108
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: OLYMPIC COOL-CAP
• Generic Name: COOL-CAP
• Product Code: MXM
• Date Received: 2018-02-22
• Model Number: 401350-503
• Operator: NURSE
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: NATUS MEDICAL INCORPORATED
• Manufacturer Address: 5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2018-02-22