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 04/02/2021

Event Type  malfunction  

Event Description

Patient returned digitrapper 24 hour ph/impedance recorder (brand new, first use) and it had error code 8 on screen.I called medtronics customer service and i was told it was a fatal error and her data could not be retrieved.The patient was wearing the recorder around her neck and it did not drop and hit anything.

• Brand Name: DIGITRAPPER
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING, INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11789747
• MDR Text Key: 249447903
• Report Number: 11789747
• 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: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• 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: 04/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22995 DA