MAUDE Adverse Event Report: MORTARA INSTRUMENT, INC ELI 250A ELECTROCARDIOGRAPH

Model Number 250A

Device Problem Electromagnetic Interference (1194)

Patient Problem No Information (3190)

Event Date 09/01/2015

Event Type  Malfunction  

Event Description

Upon obtaining a 12 lead ekg, excessive interference with tracing occurs causing some leads to be unreadable. (this has happened intermittently over 6 months. ) other devices in use during the event include telemetry, pulse oximetry, etc. However, the event has happened numerous times and the cause cannot be determined.

• Brand Name: ELI 250A
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): MORTARA INSTRUMENT, INC; 7865 north 86th street; milwaukee WI 53224
• MDR Report Key: 5093879
• MDR Text Key: 26412743
• Report Number: 5093879
• Device Sequence Number: 1
• Product Code: DPS
• 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

• Type of Report: Initial
• Report Date: 09/15/2015,09/16/2015

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 09/22/2015
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: 250A
• Was Device Available For Evaluation?: Yes

Is The Reporter A Health Professional?

• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/15/2015
• Device Age: 3 yr
• Event Location: Hospital
• Date Report TO Manufacturer: 09/15/2015
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: No Answer Provided
• Is this a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage