MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC PROTEUS ANALOG XR; SYSTEM, X-RAY, STATIONARY

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/26/2019

Event Type  malfunction  

Event Description

The table safety switch had to be replaced on the proteus analog proteus xr ge medical systems.

• Brand Name: PROTEUS ANALOG XR
• Type of Device: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha WI 53188
• MDR Report Key: 9218901
• MDR Text Key: 163172370
• Report Number: 9218901
• Device Sequence Number: 1
• Product Code: KPR
• 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: 09/24/2019,09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2019
• Event Location: Other
• Date Report to Manufacturer: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1