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

Model Number 800004

Device Problem Loss of Data (2903)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/11/2021

Event Type  malfunction  

Event Description

Patient returned her digitrapper recorder and when it was connected to the computer to upload her information, we got an error message that there was no data on it.I called medtronic for troubleshooting and it still had no data on it.This patient will have to have the test repeated.

• Brand Name: DIGITRAPPER
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING, INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12459425
• MDR Text Key: 271046559
• Report Number: 12459425
• 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: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• 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: 08/31/2021
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21900 DA