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

Model Number	8001-061-540
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly female with history of multiple sclerosis and recent cardiac workup.When applying the stryker leg warmer.The machine alarmed "check water flow".All clamps checked on tubing and machine- all clamps were open and leg wrap would still not fill with water.Leg wrap was switched, and error corrected, allowing water to flow into pad and work properly.

• Brand Name: RAPR-ROUND
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): STRYKER CORPORATION; 3800 e. centre ave; portage MI 49002
• MDR Report Key: 10966906
• Report Number: 10966906
• Device Sequence Number: 910063
• Product Code: DWJ
• UDI-Device Identifier: 07613327175073
• UDI-Public: (01)07613327175073(10)2530C5
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/04/2020
• Report Date (Section F): 12/04/2020

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: 8001-061-540
• Device Catalogue Number: 8001-061-540
• Device Lot Number: 2530C5
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/08/2020
• Patient Sequence Number: 1
• Date Report Sent to FDA: 12/04/2020