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: observation found during evaluation: when not plugged into ac power, the sr8 does not power on.The sr8 shuts off abruptly when unplugged from ac power.This is due to an internal failure within the lithium-ion battery.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
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