CASE P2 EKG STRESS SYSTEM N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-12-09 for CASE P2 EKG STRESS SYSTEM N/A manufactured by Ge Medical Systems.

Event Text Entries

[21398422] The patient was in the midst of a sestamibi treadmill stress test. During the test the patient had issues with frequent ectopy that were being closely monitored. When the patient got close to peak exercise, the monitoring system and treadmill froze, losing the ability to monitor this patient at a time when he was experiencing significant ectopy. Though the patient did not fall when the treadmill belt froze, we are concerned this could happen should this problem recur. We have had one prior occurrence of this problem in the past.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1263704
• MDR Report Key: 1263704
• Date Received: 2008-12-09
• Date of Report: 2008-12-09
• Date of Event: 2008-12-05
• Report Date: 2008-12-09
• Date Reported to FDA: 2008-12-09
• Date Added to Maude: 2008-12-16
• 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: 0
• 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 P2 EKG STRESS SYSTEM
• Generic Name: SYSTEM, ECG ANALYSIS
• Product Code: LOS
• Date Received: 2008-12-09
• Model Number: CASE P2
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: *
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 1319517
• Manufacturer: GE MEDICAL SYSTEMS
• Manufacturer Address: 9900 INNOVATION DRIVE WAUWATOSA MAILSTOP: RP2138 WI 53226 US

Device Sequence Number: 2

• Brand Name: T2100
• Generic Name: TREADMILL
• Product Code: IOL
• Date Received: 2008-12-09
• Model Number: T2100
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 1319518
• Manufacturer: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
• Manufacturer Address: 9900 INNOVATION DRIVE MAILSTOP: RP2138 WAUWATOSA WI 53226 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2008-12-09