MAUDE Adverse Event Report: MEDTRONIC INC. DIGITRAPPER PH-Z VERSAFLEX CATHETER; PH PROBE

Device Problems Failure to Power Up (1476); Off-Label Use (1494)

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

Event Date 04/12/2018

Event Type  malfunction  

Event Description

Patient scheduled for manometry with impedance catheter placement.While calibrating impedance recorder, recorder shut off while inputting patient's medical record number.Batteries were removed and replaced.Impedance recorder came back on without any issue.Calibrated catheter without any issue.Catheter placed and recorder verified to be working before patient discharge.Patient called back approximately 45 minutes after discharge and said that the recorder was not illuminating when button was pushed for meal start.Patient returned following day and the recorder was uploaded.No information had been recorded.Several of these digitrapper ph-2 monitors lost battery power soon after the patient was released from the procedure area.This was due to the wrong type of battery being placed into the monitor.The monitor requires alkaline batteries and lithium were being used.I have a rough estimate of this happening 5 times before our staff was able to figure out the problem.

• Brand Name: DIGITRAPPER PH-Z VERSAFLEX CATHETER
• Type of Device: PH PROBE
• Manufacturer (Section D): MEDTRONIC INC.; 710 medtronic pkwy; minneapolis MN 55432
• MDR Report Key: 7536784
• MDR Text Key: 109019406
• Report Number: 7536784
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/15/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT KNOWN.