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

Model Number 760

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 06/15/2016

Event Type  malfunction  

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 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
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway,gw
• Manufacturer (Section G): COVIDIEN; micheal collins rd mervue; galway,gw
• Manufacturer Contact: kelly adams ; 15 hampshire street; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 7542952
• MDR Text Key: 109226743
• Report Number: 8020893-2018-00237
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521180932
• UDI-Public: 10884521180932
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K990897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 760
• Device Catalogue Number: G-760220DIUA-EN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/05/2018
• Initial Date FDA Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/22/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 52 YR