BARD ACCESS SYSTEMS SITE-RITE 8 ULTRASOUND SYSTSEM CONSOLE (REMANUFACTURED); SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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Model Number 9770600Y |
Device Problems
Electrical /Electronic Property Problem (1198); Battery Problem (2885)
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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 received by the manufacturer for evaluation.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 (b)(4): the battery of the unit discharges quickly.This was in the middle of a procedure.Was not plugged into the wall.The battery charges; it just discharges quickly.
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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 of the unit discharges quickly was confirmed.The root cause of the reported issue is an internal failure on the battery.The device was serviced, tested and returned to customer.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 tm: the battery of the unit discharges quickly.This was in the middle of a procedure.Was not plugged into the wall.The battery charges it just discharges quickly.
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Event Description
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Per tm: the battery of the unit discharges quickly.This was in the middle of a procedure.Was not plugged into the wall.The battery charges it just discharges quickly.
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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 of the unit discharges quickly was confirmed.The root cause of the reported issue is an internal failure on the battery.The device was serviced, tested and returned to customer.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)d no other similar product complaint(s) from this serial number.
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Search Alerts/Recalls
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