MAUDE Adverse Event Report: GE MEDICAL INFORMATION TECHNOLOGIES, INC. ELECTROCARDIOGRAPH

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/19/2016

Event Type  Malfunction  

Event Description

The ekg monitor/cables were not working. The patient was with no ekg for over an hour. After switching between wires, cables, and monitors, we concluded that the ekg wires, the ekg cable and the monitor itself all malfunctioned. All three had to be changed together to get a functional ekg. No patient harm.

• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): GE MEDICAL INFORMATION TECHNOLOGIES, INC.; 465 pan american drive suite 11; el paso TX 79907
• MDR Report Key: 5784850
• MDR Text Key: 49246609
• Report Number: 5784850
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (Y/N): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/10/2016

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 07/12/2016
• Is This A Product Problem Report?: Yes

Device Operator

• OTHER Device ID Number: 401575175
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 04/19/2016

Is The Reporter A Health Professional?

• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/10/2016
• Event Location: Hospital
• Date Report TO Manufacturer: 06/10/2016
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: No Answer Provided

Is this a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient TREATMENT DATA

Date Received: 07/12/2016 Patient Sequence Number: 1

Treatment

NO