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

Model Number MAC 5500 HD

Device Problems Crack (1135); No Display/Image (1183)

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

Event Date 10/08/2018

Event Type  malfunction  

Event Description

Failure of part number 2031810-002 fru universal writer (lower case of the unit).This failure has lead to other damage including the unit will power on but the display is blank, the bottom case where the unit attaches to the trolley is cracked, the cover of the key board is cracked.

• Brand Name: MAC 5500 HD
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES; 8200 w tower ave; milwaukee WI 53223
• MDR Report Key: 8008708
• MDR Text Key: 125129680
• Report Number: 8008708
• 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: 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MAC 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: 10/18/2018
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1