MAUDE Adverse Event Report: ANDREAS FAHL MEDIZINTECHNIK VERTRIEB GMBH DURAVENT XL; TRACHEOSTOMY TUBE

Model Number	11201-07
Health Effect - Clinical Code	Death (1802)
Date of Event	05/16/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device has not returned for investigation yet.According to the physical appearance of the device on the provided pictures, most likely, the device (especially the outer cannula) seems not to be cleaned as instructed in the ifu.A detaching of a tube from the neck plate is a long-term process and will not happen all at once.Several warnings in the enclosed ifu state that the device may not be used any longer, if the material of the device appears to be discoloured or damaged.The removing of the separated cannula is comparable to a normal exchange of the device by the patient when its replaced by a new one.Important notice: due to problems with the submission via esg, we have already sent this report on friday, february 10, 2017 manually via ups express mail.In the meantime the problems with the electronic submission could be resolved, so that we also submit our report of friday, february 10, 2017 hereby electronically.Not returned to manufacturer.
Event or Problem Description
Andreas fahl medizintechnik - vertrieb (b)(4) received the information that a tracheostomy tube became detached of the neck plate while patient attempted to exchange the inner cannula.It was alleged that after having removed the entire cannula the patient passed away.

• Brand Name: DURAVENT XL
• Common Device Name: TRACHEOSTOMY TUBE
• Manufacturer (Section D): ANDREAS FAHL MEDIZINTECHNIK VERTRIEB GMBH; august-horch-str. 4a; cologne, nrw 51149 ; GM 51149
• MDR Report Key: 6328901
• Report Number: 3007913402-2017-00001
• Device Sequence Number: 773672
• Product Code: BTO
• UDI-Device Identifier: 04051948006759
• UDI-Public: 04051948006759
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K123699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2019
• Device Model Number: 11201-07
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 07022014
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2017
• Initial Report FDA Received Date: 02/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 74 YR