MAUDE Adverse Event Report: GIVEN IMAGING, INC. VERSAFLEX; ELECTRODE, PH, STOMACH

Model Number	900003
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Calibration attempted on ph probe.The recorder issued a message indicating a malfunction/failure of calibration for probe.Calibration attempted on same probe twice and attempted to calibrate same probe on a different recorder.Continued to receive malfunction/failure message.

• Brand Name: VERSAFLEX
• Common Device Name: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING, INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9362180
• Report Number: 9362180
• Device Sequence Number: 19355389
• Product Code: FFT
• UDI-Device Identifier: 04260167483740
• UDI-Public: (01)04260167483740
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2019
• Report Date (Section F): 11/13/2019

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: 900003
• Device Catalogue Number: 900003
• Device Lot Number: F1919201UA
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2019
• 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: 11/13/2019