MAUDE Adverse Event Report: COVIDIEN 980 VENTIILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	980X1ENNISB
Medical Device Problem Codes	Smoking (1585); No Flow (2991)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: a medtronic service engineer (se) inspected the ventilator but it did not start up.The se replaced the power controller and power distribution printed circuit board (pcb).When the ventilator turned on, smoke was found to be coming from the graphical user interface (gui) housing, the battery packs were noted to have their red light emitting diode (led) lit and the ventilator fan was found to be noisy.The gui assembly, battery pack and fan were replaced.The unit passed testing and operated within the manufacturing specifications and was returned to the customer.If the replaced parts are 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 or Problem Description
It was reported that while in use on a patient, the 980 ventilator shut down and had a smoking/burning smell.The patient was placed on an alternate ventilator and there was no harm to the patient as a result of the event.During evaluation of the device, smoke was found to be coming from the graphical user interface (gui) housing.

• Brand Name: 980 VENTIILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway ; IE
• MDR Report Key: 10493952
• Report Number: 8020893-2020-00146
• Device Sequence Number: 16694085
• Product Code: CBK
• UDI-Device Identifier: 10884521171749
• UDI-Public: 10884521171749
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K131252
• 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
• Report Date (Section B): 09/04/2020

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: 980X1ENNISB
• Device Catalogue Number: 980X1ENNISB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 09/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1