MAUDE Adverse Event Report:; ELECTROCARDIOGRAM

Device Problem Device Alarm System (1012)

Patient Problem Irregular Pulse (2469)

Event Date 04/25/2015

Event Type  malfunction  

Event Description

A patient had a long heart pause of 6 seconds, the monitor technician did not call for this.When the rn called to find out why he did not call, the tech said that the alarms did not go off.

• Type of Device: ELECTROCARDIOGRAM
• MDR Report Key: 4973095
• MDR Text Key: 6336675
• Report Number: 4973095
• 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

• Date FDA Received: 06/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/19/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2015
• Patient Sequence Number: 1
• Patient Age: 93 YR