GE/MARQUETTE MAC 5000 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-04-07 for GE/MARQUETTE MAC 5000 * manufactured by Ge Medical Systems Info Technologies.

Event Text Entries

[282668] Ecg leadwire mixup on ge/marquette mac 5000. An unidentified employee is believed to have switched the v5 and right leg leadwires on a ge/marquette mac 5000 ecg unit. Ecgs were taken on pts for more than 90 days before this problem was discovered by a cardiologist reading daily reports. The facility uses a rotating system of cardiologists, and time passed before it was discovered that several pts were diagnosed with similar problems when they otherwise should have had normal ecgs. This is the second time the facility has experienced this problem with a mac 5000. After the facility's initial experience, the facility contacted the mfr, and they reported that no other hospitals had complained about this type of event and that they had no recommendations for the facility to take. The facility has not contacted them since this second experience. The facility, however, devised a color-coded system for the leadwires at the proximal end and the corresponding plug on the ecg cable as a remedy to this occurrence after the facility's first experience. No inappropriate treatments have resulted from these inaccurate ecg readings.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 451831
• MDR Report Key: 451831
• Date Received: 2003-04-07
• Date of Report: 2002-10-11
• Date of Event: 2002-04-01
• Report Date: 2002-10-11
• Date Reported to FDA: 2002-10-11
• Date Added to Maude: 2003-04-08
• 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 Details

• Brand Name: GE/MARQUETTE MAC 5000
• Generic Name: ECG MACHINE LEAD WIRES
• Product Code: LOS
• Date Received: 2003-04-07
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 454986
• Manufacturer: GE MEDICAL SYSTEMS INFO TECHNOLOGIES
• Manufacturer Address: 8200 WEST TOWER AVE MILWAUKEE WI 532233219 US
• Baseline Brand Name: MAC ELECTROCARDIOGRAPH
• Baseline Generic Name: ECG ANALYSIS SYSTEM
• Baseline Model No: MAC 5000
• Baseline Catalog No: NA
• Baseline ID: NA
• Baseline Device Family: MAC ELECTROCARDIOGRAPH
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K991735
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0		2003-04-07