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

Model Number 800004

Device Problem Loss of Power (1475)

Patient Problem Insufficient Information (4580)

Event Date 06/09/2021

Event Type  malfunction  

Event Description

Patient was doing a 24 hour ph/impedance study and reported that the recorder lost power in morning.When i tried to upload the data, there was nothing on the recorder.I called customer support, but we were unable to retrieve the data.

• Brand Name: DIGITRAPPER
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING, INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12134228
• MDR Text Key: 260449822
• Report Number: 12134228
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/29/2021,06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 800004
• Device Catalogue Number: 800004
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/29/2021
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 07/08/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14965 DA