The device manufacture date is not known.This device was received at oem-wom for evaluation.Based on the oem-wom investigation report attached, the reported failure ¿there was a cardiac arrest.According to medical personnel it was caused by the medical device¿ was not confirmed.According to wom: visual inspection; the device was received on jul 7, 2022 for evaluation.There are no indications of transport damage.The lower part of the housing was slightly bent and the sealing of the gas connection was missing.However, this would have no impact the device's operation.Functional inspection: functional inspection based on procedure test instruction for fm300 v7.0 indicated the returned device passed all criteria.This included a pressure test, flow measurement test, occlusion test & venting valve (vev) & overpressure test with a result of pass.Dimensional inspection: due to the nature of the reported event, the dimensional inspection was deemed unnecessary and therefore not performed.Investigation conclusion: the results of the investigation performed indicated that the returned pneumoclear plus co2 conditioning insufflator, catalog#0620050010 rev t, sn (b)(6) is working according to specification.Probable root cause: the reported event could be not confirmed.There are no indications of a manufacturing issue.The most probable root cause could not be determined.The device was returned to the manufacturer for investigation and full functional testing was conducted.The device was found to be working per specifications.Furthermore, the reporter provided additional information which also did not imply any causative correlation between a possible malfunction and the reported serious incident.The reported failure mode will be monitored for future reoccurrence.
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