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 05/06/2018

Event Type  malfunction  

Manufacturer Narrative

Medtronic has not received the suspect device/component from the customer for evaluation nor has the service engineer evaluated the device.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 indicating a breath delivery (bd) supply and ventilation stopped.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 summary: the field service engineer (fse) replaced the backup power supply charging printed circuit board.The ventilator passed all testing per manufacturer specifications.The customer is letting the ventilator run and to verify that the issue was resolved and will return the ventilator to the clinical use in january 2019.If the replaced part is returned for failure investigation, a supplemental medwatch report with the findings will be submitted once the investigation is complete.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device evaluation summary: the field service engineer (fse) evaluated the ventilator and replaced mother board and blind mate cable to the inspiratory module.The ventilator passed all testing per manufacturer specifications and was returned to the customer.Biomedical will run the ventilator in the shop for several weeks to verify code does not return.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Evaluation summary: the inspiratory i/o cable, motherboard printed circuit board (pcb) and the back up power supply pcb were returned for failure investigation.The parts was visually inspected and functionally tested with no anomalies observed.Conclusion: there was no fault found.There was no malfunction or product deficiency identified.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: 7555319
• MDR Text Key: 109619914
• Report Number: 8020893-2018-00245
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521181045
• UDI-Public: 10884521181045
• 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,Followup,Followup
• Report Date: 02/14/2019

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: 10049998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/07/2018
• Initial Date FDA Received: 05/30/2018
• Supplement Dates Manufacturer Received: 11/15/2018; 12/06/2018; 02/12/2019
• Supplement Dates FDA Received: 11/29/2018; 12/14/2018; 02/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2013
• 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