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

Model Number	760
Medical Device Problem Code	Device Inoperable (1663)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/15/2016
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 on (b)(6) 2018 during use on a patient the 700-series ventilator abruptly stops the ventilation when the oxygen concentration is adjusted to pure oxygen.At that time, the ventilator automatically alarms to immediately replace the ventilator.The patient was removed from the ventilator and placed on an alternate ventilator with no harm reported.Between (b)(6) 2016 to (b)(6) 2018 there were several times when the ventilator did not pass the power on self-test (post).The agent engineer recommended to replace the proportional solenoid (psol) board , but the hospital management did not report to the manufacturer.

• Brand Name: PURITAN BENNETT
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway,gw
• MDR Report Key: 7542952
• Report Number: 8020893-2018-00237
• Device Sequence Number: 16619027
• 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): 05/24/2018

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2018
• Initial Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR