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Model Number ASSY, CONSOLE, BVI9600 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/20/2016 |
Event Type
malfunction
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Manufacturer Narrative
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This product has not been received for evaluation at the time of this report.The problem cannot be confirmed.If the suspect device is returned a supplemental report will be issued with the results of the evaluation.Additional part used: assy, probe, bvi 9400/9600.Catalog: 0570-0351, sn: (b)(4),.
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Event Description
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The customer reported that during a patient procedure, using a bvi9600 assy, console with probe, a measurement was take resulting in a less than 3cm aaa; this same patient later went to a hospital for an unrelated condition and while there, was discovered that the patient had a aaa which was larger than measured.No back-up device was reportedly used.No delay in the procedure was noted.No harm to patient or user was reported.
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Search Alerts/Recalls
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