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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-12-16 for * manufactured by Unk.

Event Text Entries

[119373] Echocardiography does not correlate between equipment at various locations. There is a wide variation in readings between three locations, two of which are left ventricle inside dimention systolic and ejection fraction. The first facility on 12/14/98 read left ventricle inside dimension systolic 4. 3 cm and ejection fraction 54%. The cardiologist, on 11/18/98 read left ventricle inside dimension systolic 6. 0. The second facility on 9/10/98 read left ventricle inside dimension systolic as 5. 0 and ejection fraction 45%, at the echo lab. Based on the left ventricle inside dimension systolic and the ejection fraction, drs at the second facility stated rptr should have his aortic valve replaced almost immediately since it is regurgitating and the left ventricle is expanding. If the left ventricle inside dimension systolic is over 5. 5 cm and the ejection fraction is less than 50% there becomes at this point the possible need for the replacement of the aortic valve through open heart surgery. The replacement of aortic valve is still not perfected according to the medical profession and should only be done at a stage where it becomes critical based on echocardiogram readings like left ventricle inside dimension systolic and ejection fraction. A dr wrote a recent editorial on 2/17/98 stating: because aortic valve replacement is almost always necessary and because the biological and mechanical valves still have problems resulting in significant mortality and morbidity, the decison to recommend surgery in an asymptomatic pt must wait until there are indications that changes are occurring that will predict an increased risk of death or congestive heart failure even after valve replacement. The equipment used in the three locations, did not correlate. Depending on what cardiologist one sees, the criteria used whether to operate or not depends on the cardiography readings like left ventricle inside dimension systolic and ejection fraction. Based on inaccurate readings one may be told they need open heart surgery when one really does not need the open heart surgery which could lead to death even by the surgery alone up to 8-10%. If one machine at a facility reads 4. 3 cm and another machine reads 6. 0 for left ventricle inside dimension systolic there is a serious problem related to these readings. The facility would not say that one is critical at this stage with a reading of left ventricle inside dimension systolic 4. 3 cm while the other cardiologist would say one is critical with a value of 6. 0 cm and must take the operation. The third facility stated if rptr swam in a pool he could have a heart attack, and stated he should not do aerobics, use weights on the cybic machines at the gym and should not run anymore; since in his condition he may have a heart attack. Rptr requests that an investigation be conducted on these machines since they do not correlate, the incorrect readings obtained from these machines could place a pt in for surgery when indeed open heart surgery would not be warranted. Rptr could not obtain the brand names, model on the equipment used in these three locations. Rptr wrote down the telephone numbers and would appreciate if fda would call and obtain the necessary info. With faulty info from echocardiography, many pts probably are operated for open heart surgery when indeed it is not necessary to operate because the pt is not in a critical phase. Could a standard be developed that could be used throughout the us so all the echocardiography equipment would correlate? At the first facility, the echo on 6/18/98 interpreted the dr was left ventricle inside dimension systolic 4. 0 cm and ejection fraction 50%. The echo six months later at this hosp yielded left ventricle inside dimension systolic 4. 3 cm and ejection fraction 54% on 12/14/98, interpreted by dr. The echo at the office on 11/18/98 was interpreted by a dr, with a left ventricle inside dimension systolic 6. 0 cm (bad of 5. 5 cm) which is really high. The echo at the second facility 9/10/98 was interpreted by a dr. Left ventricle inside dimension systolic 5. 0 cm and ejection fraction 45% (bad under 50%).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1015248
MDR Report Key202459
Date Received1998-12-16
Date of Report1998-12-16
Date of Event1998-12-14
Date Added to Maude1998-12-21
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand Name*
Generic NameECHOCARDIOGRAPHY EQUIPMENT
Product CodeDXK
Date Received1998-12-16
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device Availability*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key196653
ManufacturerUNK
Manufacturer AddressUNK UNK *


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Other 1998-12-16

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