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 08/15/2023 |
Event Type
malfunction
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Event Description
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It was reported this was sent for servicing.When it was returned it would fully charge with battery saying 100%.However, once it as unplugged it would not switch on, or on the odd occasion it did then it would switch itself off.We sent the unit back and it was returned to us yesterday.When we checked, it was charged to 100%.However, when we went to a ward to insert a picc, the same fault occurred again.It wouldn't switch on at all.
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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.
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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 is shutting down without warning was confirmed.The unit intermittently powers off.The issue was resolved by replacing the cmos battery and internal battery.H3 other text : evaluation findings are in section h.11.
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Event Description
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It was reported this was sent for servicing.When it was returned it would fully charge with battery saying 100%.However, once it as unplugged it would not switch on, or on the odd occasion it did then it would switch itself off.We sent the unit back and it was returned to us yesterday.When we checked, it was charged to 100%.However, when we went to a ward to insert a picc, the same fault occurred again.It wouldn't switch on at all.
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Search Alerts/Recalls
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