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

Model Number 840

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 04/26/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluation the field service engineer (fse) evaluated the ventilator and replaced the proportional solenoid valve, inspiratory flow sensor and exhalation flow sensor.The ventilator passed all testing and was placed back in clinical use.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that, while in use on a patient, a 840 ventilator generated an error code and stopped ventilating.The patient was removed from the ventilator and placed on an alternate ventilator.The patient was not harmed or injured as a result of the reported event.

Manufacturer Narrative

Device evaluation: the proportional solenoid (psol) was returned for failure investigation.The psol was installed into a failure investigation test ventilator for analysis.The unit powered up normally and no errors were recorded in the diagnostic logs.The f.I.Ventilator was put into ventilation mode for a minimum of 24 hrs using default settings as per 840 service manual.No failures occurred.The psol was functionally tested and failed testing due to the high flow unable to be adjusted.The psol was removed and the coil cover, shunt, base and locknut were replaced.The unit was once again functionally tested but failed the same symptoms.The spring pack was replaced and the psol retested.The unit passed all tests.A visual inspection of the removed spring pack assembly revealed that the armature body was not sitting correctly on the assembly.Compared to other assemblies in the manufacturing area this armature body appeared to be sitting higher on the assembly.It is not possible to breakdown the unit because during the assembly it is pneumatically p ressed to a maximum force of between 1660 and 1780lb of pressure.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional codes added to evaluation codes result and conclusion.Device evaluation summary: the inspiratory flow sensor was returned for failure investigation.A visual inspection of the returned part showed no anomalies.The unit was installed into a failure investigation (fi) test ventilator for analysis.There was no errors observed.The fi ventilator was put into ventilation mode for a minimum of 24 hrs using default settings as per 840 service manual.No failures occurred.The exhalation flow sensor was returned for failure investigation.A visual inspection of the returned part showed no anomalies.The unit was installed into a fi for analysis.There was no errors observed.The fi ventilator was put into ventilation mode for a minimum of 24 hrs using default settings as per 840 service manual.No failures occurred.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.

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: 7532132
• MDR Text Key: 108856287
• Report Number: 8020893-2018-00233
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521076891
• UDI-Public: 10884521076891
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K151252
• 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,Followup,Followup,Followup,Followup
• Report Date: 10/03/2018

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: 4-840120DIJJ-JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/27/2018
• Initial Date FDA Received: 05/22/2018
• Supplement Dates Manufacturer Received: 07/09/2018; 07/09/2018; 08/08/2018; 08/08/2018
• Supplement Dates FDA Received: 07/27/2018; 08/08/2018; 10/02/2018; 10/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2014
• 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