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

Model Number 5500 HD

Device Problems Computer Operating System Problem (2898); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 06/20/2021

Event Type  malfunction  

Event Description

Patient came into the ed with chest pain and patient was roomed.Patient was hooked up to an ekg and it would not scan after multiple attempts and then it would not bring up the data area to plug in the specifics of the patient information.We had to close the ekg machine twice to reboot and then restart.Delay of obtaining ekg with malfunctioning equipment.

• 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: 12224419
• MDR Text Key: 263388217
• Report Number: 12224419
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/28/2021

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: 5500 HD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/28/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16790 DA
• Patient Weight: 124