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 Type  malfunction  

Manufacturer Narrative

Device evaluation summary: the field service engineer (fse) inspected the device and could not duplicate the reported condition.The fse found error codes in the ventilator memory indicating a bad gui (graphic user interface) to bd (breath delivery) communication.The fse replaced the bd central processing unit (cpu) and gui label.The ventilator has passed all testing per manufacturer specifications and the ventilator was returned to the customer for 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 a severe occlusion and the safety valve opened which indicates a loss of ventilation.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

The breath delivery (bd) printed circuit board (pcb) was returned for failure investigation.A visual inspection of the returned pcb was conducted and no anomalies were found.The pcb was attached to the failure investigation test ventilator for analysis.The ventilator was powered up.During the power up self test (post), the bd diagnostic led's scanned from the centre out and back to the centre.This indicates that the bd cpu is in the download state and further, that no operating system software exists on this board.There was no software rev showing for the bdu pcb.Software version 4-070212-85-ak was loaded successfully.The ventilator was put into normal ventilation mode.The ventilator ran in ventilation mode for a minimum of 24 hours.On review of the ventilator diagnostic logs no errors were observed.No alarms were observed during the run in period.There was no fault was found on the returned bd pcb.The reported condition was not able to be duplicated.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: 7555345
• MDR Text Key: 109619883
• Report Number: 8020893-2018-00246
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884522019354
• UDI-Public: 10884522019354
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151252
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/25/2018

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: 4-840120DIUU-US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 05/30/2018
• Supplement Dates Manufacturer Received: 06/14/2018
• Supplement Dates FDA Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2006
• 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