The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been received by the manufacturer for evaluation.A history review of serial number (b)(4) showed one similar complaint from this serial number.The similar complaints have been reported by the same belgium facility.The previous complaint evaluation for this serial number (b)(4) is: inconclusive, no sample returned for evaluation.(reference: mdr number 3006260740-2022-01641).
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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 delay between movement of probe and what is showing on the screen was confirmed.The root cause of the reported failure was identified as delayed visual feedback due to software malfunction.H3 other text : evaluation findings are in section h.11.
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