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

Model Number	980
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The service engineer (se) inspected the device and replaced the mix controller board.The ventilator passed all testing per manufacturing specification and was placed back into clinical use.If the replaced part is returned for failure investigation, a supplement 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, while in use on a patient, a 980 ventilator "failed" and generated error codes.The patient was removed from the ventilator and placed on an alternate ventilator with no harm or injury.
Additional Manufacturer Narrative
Correction to section evaluation code conclusion.Additional codes added to section h6 evaluation code result.Device evaluation summary: the mix controller board was received on (b)(4) 2018.The part was visually inspected with no anomalies observed.The part was installed into a test ventilator for analysis.The ventilator passed the power on self test with no errors; however, it failed calibrations with an error message.The part was sent to it's manufacturer (sanmina) today, (b)(4) 2019, for further analysis.The manufacturer vendor ((b)(4) ) finding are as follows: damage to the component (b)(4).If information is provided in the future, a supplemental report will be issued.

• Brand Name: 980 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; michael collins road mervue; galway
• MDR Report Key: 7958840
• Report Number: 8020893-2018-00499
• Device Sequence Number: 11145656
• Product Code: CBK
• UDI-Device Identifier: 10884521171596
• UDI-Public: 10884521171596
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K162738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2019

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: 980
• Device Catalogue Number: 980X1DEDRAC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 02/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1