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 06/03/2018

Event Type  malfunction  

Manufacturer Narrative

Medtronic has not received the suspect device/component from the customer for evaluation.The customer ran the extended self-test (est) and short self-test (sst) and the unit passed testing.However, the device has been removed from service and the customer wants additional evaluation performed by medtronic.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during use, the 840 ventilator was noted to have shut down.Loss of graphical user interface (gui) and breath delivery (bd) communication error codes were provided.The patient was transferred to an alternate ventilator; however, it is unknown if there was harm to the patient as result of the event.

Manufacturer Narrative

Additional information was received on (b)(4) 2018.It was reported that the unit also had an inoperable display.A service engineer (se) inspected the device and was unable to duplicate the reported issue of shut down.During testing, the unit generated an error code associated with the graphical user interface (gui).The se replaced the breath delivery (bd) to gui cable to resolve the found issue.The unit passed testing and operated within the manufacturing specifications.If information is provided in the future, a supplemental report will be issued.

Event Description

The display was also noted to be inoperable.The patient was transferred to an alternate ventilator and there was no harm to the patient as a result of the event.

Manufacturer Narrative

Device evaluation summary: one graphical user interface (gui) to breath delivery (bd) cable was returned to medtronic for further analysis.A visual inspection of the returned component shows a slight indentation observed on the outer insulation of the cable about 17cm from the gui connector plug, along with the discoloration on the outer insulation of the cable, indicating the cable had been subject to a lot of wear and tear.The unit was attached to the failure investigation (f.I) test ventilator and it alarmed immediately indicating no communications between the gui display and the bdu generating error codes.On manipulating the cable, the communication was restored temporarily.On further investigation, using an ohmmeter, it was discovered that there was a break in the inner core of the internal co-ax cable which carries all the ethernet communications between the gui and bd printed circuit boards (pcbs).The most likely cause of this breakage might be excessive flexing or sharp bending of the cable, over time, near the point where the cable exits the gui housing.The slight indentation on the outer insulation at the same position on the cable would support this reasoning.The cause of the observed condition was determined to be the breakage of the cable.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 ave; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 7660741
• MDR Text Key: 113169161
• Report Number: 8020893-2018-00298
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• 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: 09/03/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2008
• 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