MAUDE Adverse Event Report: MMJ SA DE CV (USD) SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	6DCT
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Death (1802)
Date of Event	05/25/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, a patient was injured in a car wreck and eventually passed away.The patient was initially treated, where she underwent a tracheostomy and received treatment for various injuries suffered in the wreck.The patient was subsequently transferred to another hospital, after which she was transferred again, where she recovered from the primary acute injuries suffered in the wreck.The patient then required transport to a skilled nursing facility for the purpose of decannulation.The patient encountered difficulty breathing while at the skilled nursing facility on numerous occasions.The inner cannula of the tracheostomy was to be changed twice daily at the facility, but it was reported that this did not occur.The patient was found not breathing and was unresponsive.An ambulance was dispatched to the facility and cardiopulmonary resuscitation (cpr) was performed on the patient.The emergency medical technician (emt) suctioned the patient's tracheostomy tube and removed 30 cc of mucus from the tube.The patient was then transferred to another hospital and was pronounced dead.It is unknown at this time if the device caused or contributed to the event.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 8676973
• Report Number: 2936999-2019-00385
• Device Sequence Number: 296515
• Product Code: JOH
• UDI-Device Identifier: 20884522029015
• UDI-Public: 20884522029015
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K962173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/06/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6DCT
• Device Catalogue Number: 6DCT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 06/06/2019
• 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: 63 YR