C.R. BARD, INC. (BASD) -3006260740 SITE-RITE 8 ULTRASOUND SYSTSEM CONSOLE (REMANUFACTURED); SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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Model Number 9770600Y |
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 10/27/2022 |
Event Type
malfunction
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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 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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Failure to run on battery, shuts off after unplugging it from the wall.
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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 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 unit will not run-on battery was confirmed.The power jack on the mother board is solder fractured and the unit would not charge up.The root cause is the power jack on the motherboard is solder fractured.H3 other text : evaluation findings are in section h11.
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Event Description
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Failure to run on battery, shuts off after unplugging it from the wall.
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Search Alerts/Recalls
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