CASE 8000 EXERCISE TESTING MACHINE (EKG) * 419455-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-12-03 for CASE 8000 EXERCISE TESTING MACHINE (EKG) * 419455-001 manufactured by Ge Medical Systems Information Technologies.

Event Text Entries

[296694] The device involved with this incident was the acquisition module attached to the case 8000 stress test machine. The acquisition module is a device to which all the ekg leads used during the exercise stress test interface into the case 8000. During this particular study, the two halves of the module separated, most likely due to a stripping of the threads into which retaining screws were being used to keep both halves of the device together. When this occurred, the quality of the ekg signal coming through the module was of such poor quality that the test had to be terminated. The clinical ramifications for such a failure in this case include having to re-test the patient.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 502255
• MDR Report Key: 502255
• Date Received: 2003-12-03
• Date of Report: 2003-09-01
• Date of Event: 2003-08-01
• Date Added to Maude: 2003-12-23
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: CASE 8000 EXERCISE TESTING MACHINE (EKG)
• Generic Name: DIAGNOSTIC EXERCISE TESTING EKG MACHINE
• Product Code: LOS
• Date Received: 2003-12-03
• Model Number: *
• Catalog Number: 419455-001
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 491024
• Manufacturer: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
• Manufacturer Address: 8200 WEST TOWER AVE MILWAUKEE WI 532233219 US

Device Sequence Number: 2

• Brand Name: CASE 8000 EXERCISE TESTING MACHINE (EKG)
• Generic Name: DIAGNOSTIC EXERCISE TESTING EKG MACHINE
• Product Code: LOS
• Date Received: 2003-12-03
• Model Number: *
• Catalog Number: 419454-002
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 496921
• Manufacturer: GE MEDICAL SYSTEMS TECHNOLOGIES
• Manufacturer Address: 8200 WEST TOWER AVENUE MILWAUKEE WI 532233219 US
• Baseline Brand Name: CASE 8000 CARDIAC ASSESSMENT SYSTEM FOR EXERCISE
• Baseline Generic Name: CARDIOVASCULAR ECG ANALYSIS SYSTEM
• Baseline Model No: CASE 8000
• Baseline Catalog No: NA
• Baseline ID: NA
• Baseline Device Family: CASE 8000
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K991014
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2003-12-03