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: Other
• Report Date: 09/15/2015,09/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1