MAUDE Adverse Event Report: MORTARA INSTRUMENT, INC. ELI 380; ELECTROCARDIOGRAPH

Model Number ELI 380

Patient Problem Chest Pain (1776)

Event Date 09/01/2023

Event Type  malfunction  

Event Description

Patient in for chest pain to ed, attempted ekg but ekg machine malfunctioned.Delay in obtaining ekg on this patient for 30 min d/t equipment issue.

• Brand Name: ELI 380
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): MORTARA INSTRUMENT, INC.; 7865 north 86th street; milwaukee WI 53224
• MDR Report Key: 17780301
• MDR Text Key: 323824317
• Report Number: 17780301
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/12/2023,09/07/2023

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 Model Number: ELI 380
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/12/2023
• Date Report to Manufacturer: 09/20/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/20/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23360 DA