ULTRAMARK DIAGNOSTIC ULTRASOUND WITH HDI AND ESP 9

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-05-03 for ULTRAMARK DIAGNOSTIC ULTRASOUND WITH HDI AND ESP 9 manufactured by Advanced Technology Laboratories, Inc..

Event Text Entries

[20896240] A videotape sent by co is misleading and contains misinformation. Rptr feels that it represents the worst that an equipment mfr can offer. Blantant misrepresentations include: a) a segment called "nuchal cord" which, in rptr's opinion, does not demonstrate a nuchal cord. B) a segment called "ectopic pregnancy" that contains virtually none of the findings associated with this condition. (co representatives claim that this was "surgically proven. " rptr contends that the image is one of a "paratubal-type cyst" that was an incidental finding, if indeed an ectoptic was present). C) a segment called "oopherus (sic) cumulus" that is supposed to represent visualization of a microscopic structure; microscopic structures are not grossly visible on ultrasound examination. There are other, less obvious misrepresentations, such as questionable fetal dating, used to sell the equipment, rptr has informed them of these observations. Using their own images, it is rptr's opinion that equipment may be dangerous except in very experienced hands. The probe, which was originally designed for prostate scanning is being advertised as an endovaginal probe. In the segment called "11 week gestation," the tissue differentiation is at best poor. Rptr operated device in office for approx 2 mos. From the outset, it was rptr's opinion that something was obviously wrong. Sonographic signs upon which rptr had relied for yrs were suspiciously absent, as was good definition of the anatomy. The machine came with an applications person who remained for 3 days. By the end of the second day, rptr was able to prove to her satisfaction that even in her hands, the equipment was performing poorly, possible even non-diagnostically. She recommended that it be replaced. After an inspection by co's reps, where the machine was determined to be performing "to specs" but the image lacked "wow" as one rep said, it was replaced. Second machine did not perform significantly better. Co's assessment was unsatisfactory. In addition, rptr had examined a pt on another vendor's "low-end" piece of equipment that outperformed the "high-end. " another pt was examined both on the device and a third vendor's piece of equipment. The device was unable to define the pathology, while the other machine could. Rptr went to co. Equipment failed to do the routine pelvis studies adequately and performed questionably on the ob case during the real-time portion of co demonstration. By the time rptr was finished, one of co's employees, whose exact title rptr does not know, acknowledged, in no uncertain terms, that probe needed to be redesigned. This man was considered amoung co's most knowledgeable sonographers. Initially, this individual admitted that the probe was inadequate for rptr's practice, which he characterized as high end. Images rptr showed nor cases done in real-time were either unique or high end, but basic. Rptr suggested that equipment was unable to reliably perform routine studies. He concurred. (*)
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4000382
MDR Report Key13207
Date Received1994-05-03
Date of Report1994-03-16
Date Added to Maude1994-05-13
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameULTRAMARK DIAGNOSTIC ULTRASOUND WITH HDI AND ESP
Generic NameDIAGNOSTIC ULTRASOUND
Product CodeLXE
Date Received1994-05-03
Returned To Mfg1994-03-14
Model Number9
ID NumberC-95 IGT
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key13205
ManufacturerADVANCED TECHNOLOGY LABORATORIES, INC.
Manufacturer AddressBOTHELL WA 980413003 US


Patients

Patient NumberTreatmentOutcomeDate
10 1994-05-03

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