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 Problem
Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/04/2022 |
Event Type
malfunction
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Event Description
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Unit is not holding it's charge (b)(6) 2022 - the returned device shut down prematurely when ac power is removed.
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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 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 battery is not holding a charge was confirmed.The scanner shuts down prematurely when ac power is removed.The root cause is due to an internal li-ion battery failure due to use of the device.A history review of serial number (b)(4) showed one similar complaint from this serial number.The similar complaints have been reported by the same us facility.The previous complaint evaluation for this serial number (b)(4) is: confirmed, root cause was identified as internal li-ion battery failure.(reference: mdr number (b)(4).
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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.
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Event Description
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Unit is not holding it's charge.11/14/2022 - the returned device shut down prematurely when ac power is removed.
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