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MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE, 8.0 MM, ORAL Adverse Event — Malfunction (MDR 9611594-2020-00072)

MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE, 8.0 MM, ORAL Adverse Event — Malfunction (MDR 9611594-2020-00072) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE, 8.0 MM, ORAL; Generic name: VAP MICROCUFF ENDOTRACHEAL TUBES; M

DeviceMICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE, 8.0 MM, ORAL
Generic nameVAP MICROCUFF ENDOTRACHEAL TUBES
ManufacturerAVANOS MEDICAL INC.
Report number9611594-2020-00072
Event typeMalfunction
Product problemY
Date received2020-04-28
Report sourceHEALTH PROFESSIONAL, USER FACI
NarrativeTHE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD FOR LOT 20012113 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 27 APR 2020 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT
SourceopenFDA MAUDE (device adverse events)

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