C.R. BARD, INC. (BASD) -3006260740 SITE-RITE 8 ULTRASOUND SYSTSEM CONSOLE (REMANUFACTURED); SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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Model Number 9770600Y |
Device Problems
No Apparent Adverse Event (3189); Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/25/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been received by the manufacturer for evaluation.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
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Event Description
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Per tm - the screen turned completely blue and was frozen like that, they restarted the machine a couple of times and then it turned to an all white screen.
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Event Description
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Per tm - the screen turned completely blue and was frozen like that, they restarted the machine a couple of times and then it turned to an all white screen.
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Manufacturer Narrative
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H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the device was returned to the service facility for evaluation.During evaluation, the reported issue of blue/white screen was unconfirmed.The unit booted to the normal start-up screen during the assessment.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.
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Search Alerts/Recalls
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