MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT IRELAND 980 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	980U1ENDIUU-LA
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the service engineer.The distributor reported that the ventilator was evaluated on 2020-dec-14 and the user interface (ui) printed circuit board (pcb) was replaced.After replacement of the ui pcb, the internal battery failed which was replaced.The ventilator passed all testing and was in working condition after repair.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, when this 980 ventilator was powered on, the graphical user interface (gui) ¿appeared to have white smoke¿ and there was a ¿burnt component smell¿.The ventilator was not in use on a patient at the time of the reported event.

• Brand Name: 980 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway ; EI
• MDR Report Key: 11110864
• Report Number: 8020893-2021-00003
• Device Sequence Number: 3922940
• Product Code: CBK
• UDI-Device Identifier: 10884521201392
• UDI-Public: 10884521201392
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K131252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/04/2021

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: 980U1ENDIUU-LA
• Device Catalogue Number: 980U1ENDIUU-LA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1