BARD ACCESS SYSTEMS SITE-RITE 8 ULTRASOUND SYSTSEM CONSOLE (REMANUFACTURED); SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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Model Number 9770501 |
Device Problems
Loss of Power (1475); Battery Problem (2885); Charging Problem (2892)
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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 manufacturer has received the sample and will be evaluated.Results are expected soon.A lot history review (lhr) review is not possible, as the device is manufactured using a unique serial number and not by lot number.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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Per biomed: battery depletes within 15mins.Does not hold a charge once unplugged from wall.Unit turns off around 90% battery life.
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Event Description
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Per biomed: battery depletes within 15mins.Does not hold a charge once unplugged from wall.Unit turns off around 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 the battery will not hold a charge is confirmed.The sr8 shut off with 90% battery life.The root cause is the internal battery failed.The device was serviced, tested and returned to the customer.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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Per biomed: battery depletes within 15mins.Does not hold a charge once unplugged from wall.Unit turns off around 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 the battery will not hold a charge is confirmed.The sr8 shut off with 90% battery life.The root cause is the internal battery failed.The device was serviced, tested and returned to the customer.A history review of serial number (b)(6) showed no other similar product complaint(s) from this serial number.
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Search Alerts/Recalls
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