MAUDE Adverse Event Report: WELCH ALLYN, INC. ELI 380; ELECTROCARDIOGRAPH

Model Number	ELI380-DCXXX
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The ekg unit screen is supported by a hinge that supports the display to open and close.This hinge is getting cracked on various points and is preventing the display to light up to show the patient ekg.This has been experienced on a couple of our units so far.

• Brand Name: ELI 380
• Common Device Name: ELECTROCARDIOGRAPH
• Manufacturer (Section D): WELCH ALLYN, INC.; 4341 state street rd.; skaneateles falls NY 13153
• MDR Report Key: 20310396
• Report Number: 20310396
• Device Sequence Number: 21049454
• Product Code: DPS
• UDI-Device Identifier: 00812345026924
• UDI-Public: (01)00812345026924
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/05/2024
• Report Date (Section F): 09/05/2024

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: ELI380-DCXXX
• Device Catalogue Number: ELI380-DSC21
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 2 YR
• Date Report to Manufacturer: 09/26/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/05/2024