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

Model Number VU360

Device Problem Patient Data Problem (3197)

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

Event Date 01/30/2020

Event Type  malfunction  

Event Description

The new ekg machines do not have a hard stop requiring staff to enter a patient identifier.The urgency to perform the ekg allowed the caregiver to by-pass the field to enter in patient data.The test was run but the report could not be reliably linked to the patient because no patient information was entered prior to running the ekg.

• Brand Name: MAC
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.; 8200 west tower avenue; milwaukee WI 53223
• MDR Report Key: 10009045
• MDR Text Key: 189329634
• Report Number: 10009045
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VU360
• Device Catalogue Number: 2030360-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/02/2020
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30295 DA
• Patient Weight: 70