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

Model Number	980U3ESDIUU
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, while in use on a patient, this 980 ventilator ¿shut down¿.The patient was removed from the ventilator and placed on an alternate ventilator.It was additionally reported that the patient was in poor health and died later due to their "serious condition".The hospital staff reported that the ventilator did not cause or contribute to the patient death.
Additional Manufacturer Narrative
Device evaluation summary: medtronic conducted an investigation based upon all information received to date.It was reported that, while in use on a patient, this 980 ventilator ¿shut down¿.The device was available for evaluation.The medtronic service engineer (se) inspected the device and replaced the direct current (dc) to dc printed circuit board (pcb).The ventilator passed all testing per manufacturer specifications at the time of service.The potential cause of the event was isolated in the field to the dc to dc pcb.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality specifications.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 980 VENTIALTOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway ; EI
• Manufacturer (Section G): COVIDIEN; micheal collins rd mervue; galway ; EI
• Manufacturer Contact: kelly adams ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 12804618
• Report Number: 8020893-2021-00182
• Device Sequence Number: 17529915
• Product Code: CBK
• UDI-Device Identifier: 10884521201545
• UDI-Public: 10884521201545
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K131252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2021

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: 980U3ESDIUU
• Device Catalogue Number: 980U3ESDIUU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown