MAUDE Adverse Event Report: COVIDIEN 980 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 980

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pulmonary Emphysema (1832)

Event Type  Injury  

Manufacturer Narrative

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.

Event 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 cricoidostomy was performed and an endotracheal tube was placed while the stoma was opened more and a bovina trach was eventually placed.The service engineer (se) found no errors recorded in the ventilators memory logs and saw that all prior tests was in "pass" status.Medtronic/covidien was not authorized to evaluate/repair the device.

• Brand Name: 980 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• Manufacturer (Section G): COVIDIEN; micheal collins rd mervue; galway
• Manufacturer Contact: ray maroofian ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035334
• MDR Report Key: 6654205
• MDR Text Key: 78015184
• Report Number: 8020893-2017-06657
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131252
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 980
• Device Catalogue Number: 980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Initial Date Manufacturer Received: 06/05/2017
• Initial Date FDA Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention