MAUDE Adverse Event Report: COVIDIEN SHILEY; DISP.CAN. P-C 8-12.0 BX1

Model Number 8DCT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Dyspnea (1816)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the tracheostomy tube pilot balloon would not hold cuff pressure so they could not ventilate the patient.There was increased work of breathing and shortness of breath.After the tube was changed the patient went back to baseline with no more respiratory distress.

Manufacturer Narrative

Covidien/medtronic reference number: (b)(4).One sample was received for evaluation.Visual inspection was performed and it was observed all the components are assembled properly at tube according to applicable drawings and specifications.A functional test was performed by inflation/deflation.The cuff held the air for 24 hours.No deflation was observed.The sample was also submerged into a container filled with water and no leaks were observed.No failure mode was observed in the received sample; the complaint is not confirmed.No fault found.

• Brand Name: SHILEY
• Type of Device: DISP.CAN. P-C 8-12.0 BX1
• Manufacturer (Section D): COVIDIEN; avenida henequen; 1181 parque industrial salvarcar; cd. juarez, chihuahua ; MX
• Manufacturer (Section G): COVIDIEN; avenida henequen; 1181 parque industrial salvarcar; cd. juarez, chihuahua ; MX
• Manufacturer Contact: ray maroofian ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035334
• MDR Report Key: 6281678
• MDR Text Key: 65899722
• Report Number: 2936999-2017-00072
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8DCT
• Device Catalogue Number: 8DCT
• Device Lot Number: 16G0522JZX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 126