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

Model Number	760
Medical Device Problem Codes	Device Inoperable (1663); Incorrect Error Code (2963)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Covidien/medtronic has not received the device/component from the customer for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during use on a patient the 700 series ventilator was inoperative.There was no further details available.Although requested that it is unknown regarding the patient transfer and any harm reported.
Additional Manufacturer Narrative
Device, evaluation codes method, result and conclusion.Device evaluation: the service engineer confirmed the unit would not pass the power on self test (post) and generated error codes.The engineer replaced the missing intake cover, pressure solenoid, controller board, updated the software and navram.The ventilator passed all testing per manufacturer specifications and was returned to the customer for clinical use.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation summary: the controller printed circuit board (pcb) and the proportional solenoid (psol) pcb were returned for failure investigation.Both parts were visually inspected with no anomalies were observed.The controller pcb was evaluated on the test ventilator with no errors or alarms.There was no malfunction or product deficiency identified.The psol pcb was tested on the test ventilator.The fault was isolated to a component u38 on the pcb.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 760 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway,ie
• MDR Report Key: 7524470
• Report Number: 8020893-2018-00229
• Device Sequence Number: 16500103
• Product Code: CBK
• UDI-Device Identifier: 10884521180970
• UDI-Public: 10884521180970
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K990897
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2018

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-061949-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 05/10/2018; 06/18/2018
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 06/05/2018; 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1