C.R. BARD, INC. (BASD) -3006260740 SITE-RITE 8 ULTRASOUND; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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Model Number N/A |
Device Problems
Defective Component (2292); Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2023 |
Event Type
malfunction
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Event Description
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It was reported by biomed - shutting down when ac power is removed.Fails to run on battery.
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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 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.H3 other text : device not returned.
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Event Description
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It was reported by biomed - shutting down when ac power is removed.Fails to run on battery.
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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 shutting down when ac power is removed was confirmed.The root cause is due to an internal failure within the lithium-ion battery.H3 other text : evaluation findings are in section h11.
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