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

Model Number DP400CE

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Information (3190)

Event Date 07/27/2018

Event Type  malfunction  

Event 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
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): STRYKER MEDICAL; 3800 e. centre ave.; portage MI 49002
• MDR Report Key: 7761903
• MDR Text Key: 116458171
• Report Number: 7761903
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 07613327169324
• UDI-Public: (01)07613327169324
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DP400CE
• Device Catalogue Number: DP400CE
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/31/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1