MAUDE Adverse Event Report: COVIDIEN 760 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	G-760220DIUA-EN
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
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.(b)(6) report mentioned the following preliminary action by user:" replaced with the oxygen high-pressure tube, after the test and the pressure was normal, it could be used normally." if information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report from the (b)(6) reporting that while in use on a patient, a 760 ventilator generated an alarm and stopped ventilation.Although requested, it is unknown if a patient was transferred to another ventilator.The patient was not harmed or injured as a result of the reported event.

• Brand Name: 760 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway ; IE
• MDR Report Key: 9639760
• Report Number: 8020893-2020-00010
• Device Sequence Number: 19554242
• Product Code: CBK
• UDI-Device Identifier: 10884521180932
• UDI-Public: 10884521180932
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K990897
• 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): 01/28/2020

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: G-760220DIUA-EN
• Device Catalogue Number: G-760220DIUA-EN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1