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

Model Number CASE 8000

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Date 05/13/2022

Event Type  malfunction  

Event Description

Patient was in a cardiac stress test, in stage 2, a minute later the ekg printed and it was labeled stage 5, and the subsequent one as well.The ekg should have read, stage 2.

• Brand Name: CASE SERIES
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.; 3000 n. grandview blvd; waukesha WI 53188
• MDR Report Key: 14694834
• MDR Text Key: 294037563
• Report Number: 14694834
• 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: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CASE 8000
• 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: 06/03/2022
• Date Report to Manufacturer: 06/15/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28470 DA