MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. MAC 5500 HD; ELECTROCARDIOGRAPH

Model Number 5500 HD

Device Problems No Display/Image (1183); Failure to Power Up (1476)

Patient Problem Insufficient Information (4580)

Event Date 09/02/2021

Event Type  malfunction  

Event Description

Ekg was ordered on this patient.Upon attempting to obtain it was discovered the ekg machine was non functional.The screen would not display an image.Another ekg machine was utilized to finish the test.A delay of approx 4 minutes was caused by this.The non functional machine had been sent down for repairs.

• Brand Name: MAC 5500 HD
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.; 8200 west tower avenue; milwaukee WI 53223
• MDR Report Key: 12480318
• MDR Text Key: 271662411
• Report Number: 12480318
• 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: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5500 HD
• Device Catalogue Number: 5500 HD
• 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: 09/02/2021
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1