MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. CASE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number V6.7

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 04/26/2022

Event Type  malfunction  

Event Description

At recovery stage, the case machine instead of going to recovery, ended the test, and stopped printing ecg's.I had to print ecg's manually through all recovery.

• Brand Name: CASE
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.; 465 pan american dr ste 11; el paso TX 79907
• MDR Report Key: 14370698
• MDR Text Key: 291506392
• Report Number: 14370698
• Device Sequence Number: 1
• Product Code: DQK
• 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: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: V6.7
• 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: 05/05/2022
• Date Report to Manufacturer: 05/12/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22995 DA