MAUDE Adverse Event Report:; EKG MACHINE

Device Problems No Display/Image (1183); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 06/25/2021

Event Type  malfunction  

Event Description

Ekg machine not properly working.When leads connected to patient no rhythm showing on screen.Work order placed and attempted to call bio med for immediate attention but no answer.Patient care delayed due to ekg malfunction.Machine is being addressed in the bio med department.

• Type of Device: EKG MACHINE
• MDR Report Key: 12300583
• MDR Text Key: 265818481
• Report Number: 12300583
• 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: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29565 DA
• Patient Weight: 79