MAUDE Adverse Event Report:; ELECTROCARDIOGRAPH

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Fall (1848)

Event Date 05/15/2015

Event Type  malfunction  

• Type of Device: ELECTROCARDIOGRAPH
• MDR Report Key: 4976305
• Report Number: 4976305
• Device Sequence Number: 1
• Product Code: DPS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/19/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/06/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/19/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Age: 57 YR