MAUDE Adverse Event Report: COVIDIEN 840 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 4-840220DIUA-EN

Device Problem Smoking (1585)

Patient Problems Cyanosis (1798); Low Oxygen Saturation (2477)

Event Date 01/06/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: the (b)(4) service engineer (se) evaluated the ventilator compressor and found the start capacitor was burnt.The service engineer replaced the start capacitor and after repair, the ventilator's passed all testing and was returned to the customer.If the replaced part is returned for failure investigation, a supplemental medwatch report with the findings will be submitted once the investigation is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported by the (b)(6) food and drug administration ((b)(6)) that during use the 840 ventilator air compressor emitted smoke, followed by a pungent odor.The patient's oxygen saturation dropped to 60% and his lips became cyanotic.The patient was immediately disconnected from the ventilator and assisted with the breathing balloon.After switching to an alternate ventilator, the patient's oxygen saturation gradually increased to 92%, which did not cause any permanent impairment to the patient.

• Brand Name: 840 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway ; IE
• Manufacturer (Section G): COVIDIEN; micheal collins rd mervue; galway ; IE
• Manufacturer Contact: kelly adams ; 2101 faraday avenue; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 9735400
• MDR Text Key: 180303232
• Report Number: 8020893-2020-00029
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521077133
• UDI-Public: 10884521077133
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151252
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4-840220DIUA-EN
• Device Catalogue Number: 4-840220DIUA-EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Date Manufacturer Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2012
• 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 Age: 51 YR