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 unit will not hold a charge is confirmed.The root cause of the reported issue is an internal li-ion battery failure.The device was serviced, tested and returned to the customer.A history review of serial number (b)(4) showed one other similar complaint from this serial number.Both complaints for this serial number (b)(4) have been reported from the same facility.
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