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 No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, the unit gave out a loud noise when the patient exhaled.There was no patient injury.

Manufacturer Narrative

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: 7801753
• MDR Text Key: 117770952
• Report Number: 2936999-2018-00526
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 40884522007734
• UDI-Public: 40884522007734
• Combination Product (y/n): N
• PMA/PMN Number: K945407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2020
• Device Model Number: SSVO
• Device Catalogue Number: SSVO
• Device Lot Number: 15G1076JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Date Manufacturer Received: 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1