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); 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 10/06/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.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 biomed - intermittently freezing up in the middle of procedures.A reboot usually fixes the situation, but that is hard to do in the middle of a procedure.
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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.During the evaluation, the reported issue of the unit is freezing during procedures was unconfirmed.Could not duplicate the freezing with the scanner.There is no root cause due to no problem found.H3 other text: evaluation findings are in section h11.
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Event Description
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Per biomed - intermittently freezing up in the middle of procedures.A reboot usually fixes the situation, but that is hard to do in the middle of a procedure.
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Search Alerts/Recalls
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