MAUDE Adverse Event Report: URAL INSTRUMENT ENGINEERING / MASIMO CORPORATION AVENTA-M; VENTILATOR, CONTINUOUS, FACILITY USE

Device Problem Fire (1245)

Patient Problem Death (1802)

Event Date 05/12/2020

Event Type  Death  

Event Description

(b)(6) authorities said they would look into the safety of artificial lung ventilators being used at two hospitals after a fire broke out in (b)(6) at one of them on tuesday morning and killed five people.The blaze erupted after a ventilator in an intensive care ward treating 20 patients with the novel coronavirus burst into flames, one source told the (b)(6) news agency.It was the second fire to break out at a hospital treating coronavirus patients in less than a week.A similar fire erupted at a (b)(6) hospital on saturday, killing one person.(b)(6).Fda safety report id# (b)(4).

• Brand Name: AVENTA-M
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): URAL INSTRUMENT ENGINEERING / MASIMO CORPORATION ; 15776 laguna canyon road ; irvine CA 92618
• MDR Report Key: 10052625
• MDR Text Key: 190823396
• Report Number: MW5094477
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death