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

Model Number 760

Device Problem Defective Alarm (1014)

Patient Problem No Patient Involvement (2645)

Event Date 03/19/2018

Event Type  malfunction  

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 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
• 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 ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 7967628
• MDR Text Key: 123804394
• Report Number: 8020893-2018-00503
• 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: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 09/28/2018
• Initial Date FDA Received: 10/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2013
• 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