MAC ELECTROCARDIOGRAPH MAC5000 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2006-12-22 for MAC ELECTROCARDIOGRAPH MAC5000 NA manufactured by *.

Event Text Entries

[21255145] Customer reported that a patient encountered a delay to thrombolysis as a result of transported lead wires on the mac 5000 ecg machine. The leads that were transposed were the left arm and left leg. Ge healthcare's investigation into the reported occurrence is still ongoing. A follow-up report will be issued when the investigation has been completed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2124823-2006-00091
MDR Report Key800773
Report Source01,06
Date Received2006-12-22
Date of Report2006-12-22
Date Mfgr Received2006-11-26
Date Added to Maude2007-01-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactANN LEBAR
Manufacturer Street9900 INNOVATION DRIVE MAIL STOP RP2138
Manufacturer CityWAUWATOSA WI 53226
Manufacturer CountryUS
Manufacturer Postal53226
Manufacturer Phone4147213947
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMAC ELECTROCARDIOGRAPH
Generic NameECG ANALYSIS SYSTEM
Product CodeLOS
Date Received2006-12-22
Model NumberMAC5000
Catalog NumberNA
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key788312
Manufacturer*
Manufacturer Address* * *
Baseline Brand NameMAC ELECTROCARDIOGRAPH
Baseline Generic NameECG ANALYSIS SYSTEM
Baseline Model NoMAC5000
Baseline Catalog NoNA
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2006-12-22

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