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Model Number 9770500 |
Device Problems
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 will not hold a charge.Shuts down at 65%.
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Event Description
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Per biomed, battery will not hold a charge.Shuts down at 65%.
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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 unit shuts down with a full battery is confirmed.The battery will not hold a charge, the sr8 was powered on with 98% battery life and shutoff with 96% battery life still on it.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 will not hold a charge.Shuts down at 65%.
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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 unit shuts down with a full battery is confirmed.The battery will not hold a charge, the sr8 was powered on with 98% battery life and shutoff with 96% battery life still on it.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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Search Alerts/Recalls
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