MAUDE Adverse Event Report: STRYKER CORPORATION RAPR-ROUND; SYSTEM, THERMAL REGULATING

Model Number	8001-061-530
Health Effect - Clinical Code	Alteration In Body Temperature (2682)
Date of Event	08/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Patient is admitted status post cardiac arrest.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 temp continued to rise.
Event or Problem Description
Patient is admitted status post cardiac arrest.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 temp continued to rise.

• Brand Name: RAPR-ROUND
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): STRYKER CORPORATION; 3440 s dearborn st ste 215-s; chicago IL 60616
• MDR Report Key: 7822183
• Report Number: 7822183
• Device Sequence Number: 1052955
• Product Code: PLA
• UDI-Device Identifier: 00857915006166
• UDI-Public: (01)00857915006166
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2018
• Report Date (Section F): 08/15/2018

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: Health Professional
• Device Model Number: 8001-061-530
• Device Catalogue Number: 8001-061-530
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 09/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 08/15/2018