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Adverse Event Report

ADVANCED TECHNOLOGY LABORATORIES, INC. ULTRAMARK DIAGNOSTIC ULTRASOUND WITH HDI AND ESP   back to search results
Model Number 9
Event Description

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. (*).

 
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Brand NameULTRAMARK DIAGNOSTIC ULTRASOUND WITH HDI AND ESP
Type of DeviceDIAGNOSTIC ULTRASOUND
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
ADVANCED TECHNOLOGY LABORATORIES, INC.
bothell WA 98041 3003
Device Event Key13205
MDR Report Key13207
Event Key9630
Report NumberMW4000382
Device Sequence Number1
Product CodeLXE
Report Source Voluntary
Report Date 03/16/1994
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/03/1994
Is This An Adverse Event Report? No
Device Operator Health Professional
Device MODEL Number9
OTHER Device ID NumberC-95 IGT
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/14/1994
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on December 31, 2008

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