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 Date 04/26/2017

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 a "connection failure alarm", and was followed by an occlusion alarm a few minutes later.It was reported that the ventilator continued to ventilate the patient however, 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 could not duplicate the reported issue.During testing, the se shut the ventilator off, and when the ventilator turned back on, the ventilator generated inoperable error messages.The device is undergoing evaluation and repair but has not yet been completed.

Manufacturer Narrative

Product analysis: an inspiratory module was returned to covidien/ medtronic¿s product analysis.A visual inspection of the returned component was performed, no notable conditions were found.The returned component was installed into a test ventilator for analysis; no errors were recorded in the diagnostic logs and functionality testing was performed.An investigation was performed and the product analysis technician reported that no fault was found.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: 6589614
• MDR Text Key: 75915677
• Report Number: 8020893-2017-06240
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 02/09/2018

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: 10/10/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/26/2017
• Initial Date FDA Received: 05/24/2017
• Supplement Dates Manufacturer Received: 02/07/2018
• Supplement Dates FDA Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2017
• 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