Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A review of the device history records has been requested.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturing date: 18january2012.Manufacturing location: (b)(4).Device part 03.501.080 lot 7738572 is a batch number controlled product, therefore no service history record review is possible.Device history record (dhr) review result below.No non-conformance reports, rework or other relevant quality notifications were referenced in the device history record.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The conclusion of the dhr review is that the final product, met inspection records, certification test values, and acceptance criteria.A product investigation was completed: the following failure has been reported: general, missing parts.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The service technician noted the action taken as activity, exchange, replacement.During the pre-repair diagnostic assessment the service technician identified the failure code as general, missing parts.The service technician identified the probable root cause as undetermined, not determinable.The device was repaired and returned to the customer.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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