MAUDE Adverse Event Report:; ELECTROCARDIOGRAM

Device Problems Use of Device Problem (1670); Device Displays Incorrect Message (2591); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/13/2015

Event Type  malfunction  

Event Description

Ecg error for missing/incomplete/incorrect secondary id #.Team member failed to follow and demonstrate procedure instructions as stated in policy #3040 12 lead electrocardiogram (ecg).

• Type of Device: ELECTROCARDIOGRAM
• MDR Report Key: 4942094
• MDR Text Key: 6038260
• Report Number: 4942094
• 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: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2015
• Is this an Adverse Event Report?: No
• 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: 07/02/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2015
• Patient Sequence Number: 1
• Patient Age: 47 YR