C.R. BARD, INC. (BASD) -3006260740 SITE~RITE 8 ULTRASOUND SYSTEM CONSOLE WITH CONNECTOR; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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Model Number 9770600 |
Device Problems
No Apparent Adverse Event (3189); Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/09/2022 |
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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The probe is no longer working, and the screen keeps going black.
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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 the information, the following was concluded: the device was returned to the service facility for evaluation.During evaluation, the reported issue of the unit shuts down without warning was unconfirmed.The unit is giving a bright and clear image.The customer did not send in the probe.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.
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Event Description
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The probe is no longer working, and the screen keeps going black.
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Search Alerts/Recalls
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