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

Model Number 980U1ENDIUU-LA

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2020

Event Type  malfunction  

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 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
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway ; EI
• Manufacturer (Section G): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway ; EI
• Manufacturer Contact: kelly adams ; 2101 faraday avenue; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 11110864
• MDR Text Key: 224868339
• Report Number: 8020893-2021-00003
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521201392
• UDI-Public: 10884521201392
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K131252
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 980U1ENDIUU-LA
• Device Catalogue Number: 980U1ENDIUU-LA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/22/2020
• 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