MAUDE Adverse Event Report: WELCH ALLYN, INC. WELCH ALLYN, INC.; ELECTROCARDIOGRAPH

Model Number ELI380

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2023

Event Type  malfunction  

Event Description

Articulating screen on eli380 causes the cable for the screen function to fail.The screen no longer functions well when this happens.This has happened on nearly all the devices in the facility.

• Brand Name: WELCH ALLYN, INC.
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): WELCH ALLYN, INC.; 7900 north 86th st; milwaukee WI 53224
• MDR Report Key: 19040463
• MDR Text Key: 339357204
• Report Number: 19040463
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/30/2023

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 Operator: Other
• Device Model Number: ELI380
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/30/2023
• Device Age: 2 YR
• Date Report to Manufacturer: 04/04/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2024
• Type of Device Usage: Unknown
• Patient Sequence Number: 1