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

Model Number	760
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the service engineer evaluated the ventilator and replaced the pressure solenoid (psol) printed circuit board (pcb); after repairs the unit passed all tests and manufacturer¿s specifications.The replaced psol pcb was returned to medtronic for analysis.The analysis isolated the fault to electronic component u37.The reported complaint mode will be utilized for trending purposes and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the 700 series ventilator has failed the power on self test (post) and generated power on alarm.The ventilator was not in use on a patient at the time of the reported event.

• Brand Name: 760 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway,gw
• MDR Report Key: 7967628
• Report Number: 8020893-2018-00503
• Device Sequence Number: 10804406
• 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: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/15/2018

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: 760
• Device Catalogue Number: G-760220DIUA-EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 10/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1