MAUDE Adverse Event Report: STRYKER MEDICAL; SYSTEM, THERMAL REGULATING

Model Number	DP400CE
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Stryker esophageal probe (which connects to blanketrol) placed times two requiring two x-rays to confirm placement.Unable to visualize on both films.

• Brand Name: NA
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): STRYKER MEDICAL; 3800 e. centre ave.; portage MI 49002
• MDR Report Key: 7761903
• Report Number: 7761903
• Device Sequence Number: 1793289
• Product Code: DWJ
• UDI-Device Identifier: 07613327169324
• UDI-Public: (01)07613327169324
• 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
• Report Date (Section B): 07/31/2018
• Report Date (Section F): 07/31/2018

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: No Information
• Device Model Number: DP400CE
• Device Catalogue Number: DP400CE
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2018
• 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: 07/31/2018