BARD ACCESS SYSTEMS SITE-RITE 8 ULTRASOUND SYSTEM W/PINPOINT GT; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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Model Number 9770501 |
Device Problems
Battery Problem (2885); Power Problem (3010)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned to the manufacturer, at this time, for evaluation.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.
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Event Description
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Biomed reported system shuts down at 90% battery life.
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Manufacturer Narrative
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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 shuts down at 90% battery life was confirmed.Root cause confirmation the problem is confirmed.The scanner was charged to 100%, when the ac adaptor was removed the scanner ran on battery power for less than 5 minutes.The root cause is an internal failure in the lithium-ion battery.No other functionality issues were found with the equipment during evaluation/servicing.The device was serviced, tested, and returned to the customer.A history review of serial number dybnac014 showed no other similar complaint(s) from this serial number.
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Event Description
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Biomed reported system shuts down at 90% battery life.
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Manufacturer Narrative
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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 shuts down at 90% battery life was confirmed.Root cause confirmation the problem is confirmed.The scanner was charged to 100%, when the ac adaptor was removed the scanner ran on battery power for less than 5 minutes.The root cause is an internal failure in the lithium-ion battery.No other functionality issues were found with the equipment during evaluation/servicing.The device was serviced, tested, and returned to the customer.A history review of serial number (b)(6) showed no other similar complaint(s) from this serial number.
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Event Description
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Biomed reported system shuts down at 90% battery life.
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Search Alerts/Recalls
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