MAUDE Adverse Event Report: MALLINCKRODT MEDICAL SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	70XLTCP
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Extubate (2402)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic received additional information from the customer stating that the series of events that occurred were primarily due to patient weight and not any of medtronic's products.This event is being reported due to the medical intervention and re-incubations of the patient.
Event or Problem Description
It was reported that, while the 980 ventilator was being used on a patient, complications with the patient occurred.The customer stated that the ventilator performed and alarmed as intended with no malfunction.It is the customer's belief that the larynx migrated over time, causing the shiley 8.0 cuffed trach to dislodge between tracheal rings and adipose tissue, resulting in bilateral pneumothoraces and subcutaneous emphysema.As a result, the patient was taken to the operating room and a 2nd trach was placed (shiley 7 xlt) which was reportedly still not long enough.An emergency cricoidectomy was performed and an endotracheal tube was placed while the stoma was opened more and a bovina trach was eventually placed.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810
• MDR Report Key: 6671478
• Report Number: 8020889-2017-05061
• Device Sequence Number: 964458
• Product Code: JOH
• UDI-Device Identifier: 10884522027908
• UDI-Public: 10884522027908
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K051416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2017

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: Health Professional
• Device Expiration Date: 03/12/2018
• Device Model Number: 70XLTCP
• Device Catalogue Number: 70XLTCP
• Device Lot Number: 201303203X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2017
• Initial Report FDA Received Date: 06/27/2017
• 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: Required Intervention