This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: connection issue probable root cause: 1.Software malfunction 2.Power supply malfunction 3.Insufflator design 4.Unwanted movement of internal components / wiring 5.Use error 6.Electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge 7.Mio board malfunction 8.Bam board malfunction 9.Lcd assembly failure 10.Manufacturing/ service error the reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.Please note we are discontinuing the current practice of filing malfunction medical device reports (mdrs) for reported complaints related to tubing disconnection on pneumosure tubesets.The initial event of this failure was filed on (b)(6) 2017, as a serious injury, mdr (b)(4).This malfunction has not caused or contributed to any further deaths or serious injuries for two years.Therefore, we will discontinue filing mdrs for pneumosure tubesets due to potential loss of insufflation during surgery due to tubing disconnection.This will be the last filing related to tubing disconnection on tubesets for pneumosure.H3 other text : 81.
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