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

Model Number	840
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the medtronic service engineer evaluated the ventilator and found that the compressor was physically burnt and required replacement.The compressor has been requested from customer and they have agreed to release the compressor to medtronic for failure investigation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during patient use, the pb840 ventilator compressor physically burnt.The patient was removed from the ventilator and placed on an alternate ventilator without harm.
Additional Manufacturer Narrative
Concomitant medical products: device evaluation summary: the pb840 ventilator 806 compressor was returned for failure investigation.It was reported that during use the pb840 ventilator 806 compressor caught fire and had burned.This caused extensive damage to some of the main components of the compressor.The fire was confined to the inside of the chamber.A visual inspection of the returned compressor was conducted, and the following was observed: the compressor external covers, while showing some evidence of thermal damage, were mostly intact.The damage was primarily centered in the lower right-hand side of the compressor.The source of the fire was most probably the motor start capacitor device as the surrounding area is where the most intense heat occurred.The right-hand side of the capacitor had fully disintegrated.A review of the compressor device history record (dhr) indicates that the compressor motor serial number: ((b)(4)) was installed in the compressor and manufactured in april 2004.The original compressor motor was still in place at the time of the reported event.The ventilator and compressor were designed with an expected life of twelve years.Details of the fault and compressor were forwarded to the vendor.They were unable to determine a root cause.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 8605390
• Report Number: 8020893-2019-00108
• Device Sequence Number: 16737192
• Product Code: CBK
• UDI-Device Identifier: 10884521077096
• UDI-Public: 10884521077096
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K151252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2019

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
• Operator of Device: Health Professional
• Device Model Number: 840
• Device Catalogue Number: 4-840220DIPC-PL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 07/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1