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	08/06/2018
Type of Reportable Event	Malfunction
Additional 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.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 had a loss of ventilation as it stopped cycling and generated a device alert with an error code.The patient was removed from the ventilator and manually ventilated via an ambu bag before being placed on an alternate ventilator.The patient was not harmed or injured as a result of the reported event.
Additional Manufacturer Narrative
Additional information: the field service engineer evaluated the ventilator and performed testing per manufacturer specifications.Additional details of event and repair have been requested.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The service engineer (se) inspected the device and found an error code.The ventilator passed all testing per manufacturing specification and was placed back into clinical use.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: 7794965
• Report Number: 8020893-2018-00378
• Device Sequence Number: 19160908
• Product Code: CBK
• UDI-Device Identifier: 10884521171619
• UDI-Public: 10884521171619
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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,Followup
• Report Date (Section B): 12/05/2018

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: 980X1PLDIPC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 11/19/2018; 11/30/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 11/19/2018; 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1