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  

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 in use on a patient, a 980 ventilator generated an occlusion error message.The customer reported to have replaced the occluded expiratory filter and then the ventilator generated an exhalation flow sensor (evq) error message.The patient was removed from the ventilator and placed on an alternate ventilator.The patient was not harmed or injured as a result of the reported event.The evaluation and repair of the device has not been completed.

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 in use on a patient, a 980 ventilator generated an occlusion error message.The customer reported to have replaced the occluded expiratory filter and then the ventilator generated an exhalation flow sensor (evq) error message.The patient was removed from the ventilator 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 and was not able to duplicate the reported issue.The se found the tubing to be damaged which could have contributed to the reported issue.The se performed extended self-testing on the device and all tests passed.

• 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: 6421583
• MDR Text Key: 70479980
• Report Number: 8020893-2017-05325
• 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,health
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 02/21/2017

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: 02/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2017
• Initial Date FDA Received: 03/21/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2014
• 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