MAUDE Adverse Event Report: WELCH ALLYN PROPAQ ENCORE; MONITOR, CARDIAC

Device Problems No Display/Image (1183); Device Displays Incorrect Message (2591)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 01/08/2015

Event Type  malfunction  

Event Description

The nurse was planning to transport a patient that had recently had chest pain to the stress lab on a portable monitor.The patient was placed on the monitor but no ecg tracing appeared.After troubleshooting the settings, the same cable was plugged into different portable monitor.On both screens, the message "ecg fault" was displayed.The patient was switched to an alternative ecg cable and issue was resolved.A biomed work-order was placed to repair and address the issue.

• Brand Name: PROPAQ ENCORE
• Type of Device: MONITOR, CARDIAC
• Manufacturer (Section D): WELCH ALLYN; 4341 state street rd.; skaneateles falls NY 13153
• MDR Report Key: 4767952
• MDR Text Key: 5951897
• Report Number: 4767952
• Device Sequence Number: 1
• Product Code: DRT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 04/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/17/2015
• Event Location: Hospital
• Date Report to Manufacturer: 05/13/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/17/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR