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

Model Number 980

Device Problem Occlusion Within Device (1423)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that, while in use on a patient, a 980 ventilator generated a severe occlusion alarm.The patient was removed from the ventilator, bagged and placed on an alternate ventilator.The patient was not harmed or injured as a result of the reported event.The service engineer (se) inspected the device, however, the repair of the device has not been completed.

Manufacturer Narrative

The service engineer (se) inspected the device and found the exhalation flow sensor was missing the rubber seal.The se replaced the rubber seal kit, updated the software to the current revision, performed calibrations, extended self-testing on the device and all tests passed.If information is provided in the future, a supplemental report will be issued.

• 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: 6555919
• MDR Text Key: 74789167
• Report Number: 8020893-2017-06033
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/14/2017

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?: Yes
• 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: 04/25/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2017
• Initial Date FDA Received: 05/09/2017
• Supplement Dates Manufacturer Received: 04/25/2017
• Supplement Dates FDA Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2014
• 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