ELI 200 INTERPRETIVE ELECTROCARDIOGRAPH MACHINE 510 K# K920626

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-05-19 for ELI 200 INTERPRETIVE ELECTROCARDIOGRAPH MACHINE 510 K# K920626 manufactured by Mortara Instruments.

Event Text Entries

[1549763] Mr. (b) (6) was a (b) (6) male with no prior history of cardiovascular disease, who was seen by his family practice physician on the morning of (b) (6) 2007 for complaints of sharp back pain. Vital signs were normal with a heart rate of 64 beats per minute. An electrocardiogram - ecg - was ordered using a mortara instruments eli 200 interpretive electrocardiograph machine. The first ecg showed only excessive movement artifact. A second ecg was obtained with no movement or artifact and this ecg interpretation printed "wolff-parkinson-white type b" - despite severe st segment elevation present in all pre-cordial leads-. A third ecg ordered and despite having both 2mm and 3mm st segment elevations present in the anterior-lateral leads, printed only an interpretation of: "wolff-parkinson-white type b". The pt was discharged with follow up scheduled for a new diagnosis of "wolff-parkinson-white type b" however, the pt died before his appointment. Autopsy revealed he died of a massive antero-lateral myocardial infarction. Since this pt death, our engineers have studied this particular electrocardiograph machines interpretive algorithm and have found evidence of a crucial error in the design of the interpretive algorithm. We have also discovered serious and faulty interpretive criteria for the algorithms diagnosis of wolff-parkinson-white type a and b. Dates of use: (b) (6) 2007 - (b) (6) 2007. Diagnosis or reason for use: acute sharp back pain, shortness of breath, dizziness.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5016035
MDR Report Key1697498
Date Received2010-05-19
Date of Report2010-05-19
Date of Event2007-09-29
Date Added to Maude2010-05-26
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameELI 200 INTERPRETIVE ELECTROCARDIOGRAPH MACHINE
Generic NameINTERPRETIVE ELECTROCARDIOGRAPH MACHINE
Product CodeLOS
Date Received2010-05-19
Model NumberELI 200
Catalog Number510 K# K920626
ID NumberPRODUCT CODE: LOS
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerMORTARA INSTRUMENTS
Manufacturer AddressMILWAUKEE WI 53224343 US 53224 3431


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2010-05-19

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