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

Model Number 840

Device Problem Occlusion Within Device (1423)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that, an 840 ventilator went into safety valve occluded and the device became inoperative.The ventilator was not in use on a patient at the time the malfunction occurred.The service engineer (se) verified the malfunction and replaced the safety valve.The unit passed all testing and operates within the manufacturing specifications.

Manufacturer Narrative

Device evaluation summary: one safety valve was returned to medtronic for further analysis.The unit was attached to the failure investigation (f.I) test ventilator and it failed extended self test (est).The unit was removed from the f.I.Ventilator and it was noted that the sv magnetic housing which is connected to the sv base plate was loose and the lock nut was also loose.The unit was brought to the 840 sv assembly area where the unit was disassembled, and the magnetic housing was re pressed in the pneumatic press fixture.The unit was once again installed into the f.I test ventilator; successfully passed all tests and no errors were recorded in the diagnostic log.Put the ventilator into ventilation mode for a minimum of 24 hours; no errors were observed on the ventilator diagnostic and alarm logs.The investigation isolated the failure to the loose connection, but a cause was not identified.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 92008 ; 7606035046
• MDR Report Key: 6525377
• MDR Text Key: 73800635
• Report Number: 8020893-2017-05854
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K151252
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2018

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: 4-840220DIUA-EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2017
• Initial Date FDA Received: 04/27/2017
• Supplement Dates Manufacturer Received: 07/17/2018; 08/08/2018
• Supplement Dates FDA Received: 07/18/2018; 10/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2014
• 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