C.R. BARD, INC. (BASD) -3006260740 SITE~RITE 8 ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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Model Number N/A |
Device Problem
Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/21/2023 |
Event Type
malfunction
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Event Description
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It was reported the unit keeps turning off when in use.
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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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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 service facility for evaluation.During evaluation, the reported issue of the unit shuts down without warning was confirmed.The units battery needs to be swapped.The root cause of the failure was identified as an internal battery failure.H3 other text : evaluation findings are in section h11.
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Event Description
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It was reported the unit keeps turning off when in use.
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Search Alerts/Recalls
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