C.R. BARD, INC. (BASD) -3006260740 SITE~RITE PREVUE SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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Catalog Number 9770239 |
Device Problems
Failure to Charge (1085); Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/18/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been received by the manufacturer for evaluation.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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The equipment is heating up a lot, even when it is turned off, when it is being charged with energy.And in use, it shows that the device's battery is half full, the symbol for turning the device off appears on the screen.
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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 system overheating was confirmed.It was identified that the battery must be replaced.This is the root cause of the heating.A history review of serial number (b)(6) showed no other similar product complaint(s) from this serial number.
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Event Description
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The equipment is heating up a lot, even when it is turned off, when it is being charged with energy.And in use, it shows that the device's battery is half full, the symbol for turning the device off appears on the screen.
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Search Alerts/Recalls
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