BARD ACCESS SYSTEMS SITE-RITE 8 ULTRASOUND SYSTSEM CONSOLE (REMANUFACTURED); SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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Model Number 9770600Y |
Device Problems
Failure to Charge (1085); 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 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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Per biomed, unit will not hold a charge.It works when plugged in but shuts down when removed from the wall.
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Event Description
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Per biomed, unit will not hold a charge.It works when plugged in but shuts down when removed from the wall.
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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 scanner shuts off prematurely after ac power is removed.The root cause of the reported issue is an internal li-ion battery failure.No other functionality issues with the equipment were found during evaluation/servicing.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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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 scanner shuts off prematurely after ac power is removed.The root cause of the reported issue is an internal li-ion battery failure.No other functionality issues with the equipment were found during evaluation/servicing.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, unit will not hold a charge.It works when plugged in but shuts down when removed from the wall.
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Search Alerts/Recalls
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