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 battery shuts down was confirmed.The rite 8 site was visually inspected upon receipt and showed no physical damage.The reported problem was confirmed, the equipment shuts down after removal of the power supply and only stays on if it is connected to power.The main cause of the problem was a premature failure of the lithium battery that does not charge.The battery has the number of cycles below the critical value (number of cycles: 42) but does not provide the correct voltage for proper operation of the equipment.A history review of serial number dycxad518 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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