MAUDE Adverse Event Report: COVIDIEN 740 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 740

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 05/02/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: the technician evaluated the ventilator and confirmed that around the capacitor inside the pressure solenoid had burned.A test pcb was installed and the ventilator started working as per the service manual specifications.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during use on patient the 740 ventilator's screen blacked out and generated an alarm of operation failure.The safety valve open lamp was blinking.The nurse stated that there was a "burn smell".Later, a technician confirmed that around the capacitor inside the pressure solenoid printed circuit board (pcb) had burned.The patient was removed from the ventilator and placed on an alternate ventilator with no harm reported.

• Brand Name: 740 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway,gw
• Manufacturer (Section G): COVIDIEN; micheal collins rd mervue; galway,gw
• Manufacturer Contact: kelly adams ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 7549912
• MDR Text Key: 109430414
• Report Number: 8020893-2018-00241
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K990897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 740
• Device Catalogue Number: G-740110DIUU-JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2011
• 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