MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO SM/M VEST BLKT ASSY CLIK TITE; SYSTEM, THERMAL REGULATING

Catalog Number	8001061530
Health Effect - Clinical Code	Alteration In Body Temperature (2682)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported by user facility medwatch (b)(4): patient is admitted post cardiac arrest.The md ordered hypothermia protocol to be applied.Obtained cooling wraps/blanket with a goal temp of 36.Cooling blanket states it is cooling patient with a water temperature of 27.Cooling blanket feels as though it is room temperature, and the patient's temperature continued to rise.
Additional Manufacturer Narrative
The user facility was unable to identify the settings or the unit used during the alleged event.Device could not be identified.
Event or Problem Description
The following was reported by user facility medwatch (b)(4): patient is admitted post cardiac arrest.The md ordered hypothermia protocol to be applied.Obtained cooling wraps/blanket with a goal temp of 36.Cooling blanket states it is cooling patient with a water temperature of 27.Cooling blanket feels as though it is room temperature, and the patient's temperature continued to rise.

• Brand Name: SM/M VEST BLKT ASSY CLIK TITE
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 8016222
• Report Number: 0001831750-2018-01420
• Device Sequence Number: 13798089
• Product Code: DWJ
• UDI-Device Identifier: 07613327175080
• UDI-Public: 07613327175080
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 8001061530
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1