MAUDE Adverse Event Report: MEDTRONIC INC DIGITRAPPER PH-Z RECORDER; PH MONITOR

Model Number PH-Z

Device Problems Loss of Power (1475); Off-Label Use (1494)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2018

Event Type  malfunction  

Event Description

Ph monitoring catheter placed and functionality verified prior to patient leaving our facility.New batteries in device and device reads batteries have full charge.Patient understands how to use the devise and demonstrates understanding.Device works appropriately for approximately 5 hours at home and shuts off without being turned off.The patient states she did not damage, drop or injury the device in any way.The patient called as directed if problems occur, but we were unable to troubleshoot the device.I contacted medtronic the next day when the patient returned the receiver device and worked with the manufacturer's tech; we were unable to retrieve information from the device.The device will be sent in for repair.The patient was not injured in any way from this equipment failure.We had a least (b)(4) cases that this happened with.The issue was that we were using lithium batteries in the monitor and it should only be used with alkaline.The rep was the one who discovered this issue.

• Brand Name: DIGITRAPPER PH-Z RECORDER
• Type of Device: PH MONITOR
• Manufacturer (Section D): MEDTRONIC INC; 710 medtronic pkwy; minneapolis MN 55432
• MDR Report Key: 7536744
• MDR Text Key: 109019258
• Report Number: 7536744
• 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
• Device Model Number: PH-Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• 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 APPLICABLE.