MAUDE Adverse Event Report: COVIDIEN 840 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	4-840120DIUU-US
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation device summary: medtronic conducted an investigation based upon all information received.The device was not made available for evaluation.The customer resolved the issue by performing extended self-test (est) and short self-test (sst).It was reported that while in use on a patient, this 840 ventilator stopped working and generated ventilator inoperative diagnostic codes.The reported issue could not be confirmed.The most likely root cause could not be established from the information available.The manufacturing records for each device are also thoroughly reviewed prior to release to ensure that products meet all medtronic quality specifications.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, this 840 ventilator stopped working and generated ventilator inoperative diagnostic codes.The patient was manually ventilated via an ambu bag prior to transferring to an alternate ventilator without harm.

• Brand Name: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway ; EI
• MDR Report Key: 11066272
• Report Number: 8020893-2020-00206
• Device Sequence Number: 19552137
• Product Code: CBK
• UDI-Device Identifier: 10884522019354
• UDI-Public: 10884522019354
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K970460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2020

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: 4-840120DIUU-US
• Device Catalogue Number: 4-840120DIUU-US
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR