MAUDE Adverse Event Report: COVIDIEN 840 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 840

Device Problem Failure To Run On AC/DC (1001)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: the field service engineer evaluated the ventilator and replaced the power supply.The ventilator passed all tests and calibrations; operates within medtronic specifications upon completion of service.The tamura (taiyo yuden) power supply was returned for failure investigation.A visual inspection of the returned part was conducted and no anomalies were observed.The part was attached to the failure investigation test ventilator for analysis.The ventilator was powered up bit failed at the power up stage with error codes.The fault was isolated to the v3 (+15v) and v4 (-15v) rails to the bdu breath delivery unit.The voltage rails were out of specification, reading approximately +6v and +0.6v respectively, when they should have been reading +15v and -15v respectively.All other voltage rails were reading within specification.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that an 840 ventilator generated ventilator inoperable error codes.The ventilator was not in use on a patient at the time of the event.

• Brand Name: 840 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• Manufacturer (Section G): COVIDIEN; micheal collins rd mervue; galway
• Manufacturer Contact: kelly adams ; 2101 faraday avenue; carlsbad, CA 92002 ; 7606035046
• MDR Report Key: 7664899
• MDR Text Key: 113282891
• Report Number: 8020893-2018-00302
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521077188
• UDI-Public: 10884521077188
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K151252
• 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: 07/05/2018

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: 840
• Device Catalogue Number: 4-840220DRAC-GR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Initial Date Manufacturer Received: 06/19/2018
• Initial Date FDA Received: 07/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2004
• 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