MAUDE Adverse Event Report: MMJ SA DE CV (USD) SHILEY; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number SSVO

Device Problem Noise, Audible (3273)

Patient Problem Dyspnea (1816)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the units were generating a 'ssssst" sound when it's being used.The customer reported that the patient had difficulty breathing when using the device.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the units were generating a 'ssssst" sound when it's being used.The customer reported that the patient had difficulty breathing when using the device.It was also reported that the patient could breathe daily with 4 liters oxygen support in speaking valve.It was also reported that the tube was cuffed, fenestrated and deflated, each speaking valve was immediately removed as it was observed after a few minutes that device did not work normally.

Manufacturer Narrative

Evaluation summary: one sample was received for evaluation.A visual inspection was performed and no cuts, deformities or damage was observed in the mem brane nor the diaphragm, the membrane is in the right position.Therefore, no failure mode was observed in the received sample since met with the product specifications and no corrective actions are required.Information has been added to the database and trends will continue to be monitored.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SHILEY
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 8032618
• MDR Text Key: 125930469
• Report Number: 2936999-2018-00665
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 40884522005372
• UDI-Public: 40884522005372
• Combination Product (y/n): N
• PMA/PMN Number: K945407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2022
• Device Model Number: SSVO
• Device Catalogue Number: SSVO
• Device Lot Number: 17A0573JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Date Manufacturer Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other