H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.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 ultrasound is powering off when unplugged.Will not turn on unless plugged in, even though battery is >50% was confirmed.The unit shuts down when not connected to ac power.The root cause is due to the lithium-ion battery.A history review of serial number dybxac511 showed no other similar product complaint(s) from this serial number.H3 other text : evaluation findings are in section h.11.
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