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

Model Number	980S1ENDICU
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the service engineer (se) inspected the device and found diagnostic codes.The se replaced the dc (direct current) to dc converter printed circuit board assembly (pcba).The ventilator passed all testing per manufacturing specification and was placed back into clinical use.One dc-dc converter pcba was received by medtronic for evaluation.A visual inspection of the returned part was conducted with no anomalies observed.Testing was performed and after approximately ten minutes the ventilator alarmed with and generated error codes.The fault was isolated to the c83 on the returned pcba.Conclusion: root cause assigned c83 electronic component failure.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, a 980 ventilator generated a high priority alarm that could not be silenced or reset and a safety valve open alert condition.The patient was removed from the ventilator and placed on an alternate ventilator with no harm or injury.

• Brand Name: 980 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway ; EI
• MDR Report Key: 11012905
• Report Number: 8020893-2020-00195
• Device Sequence Number: 13670394
• Product Code: CBK
• UDI-Device Identifier: 10884521171114
• UDI-Public: 10884521171114
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 12/15/2020

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: 980S1ENDICU
• Device Catalogue Number: 980S1ENDICU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 12/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 97