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) evaluated the ventilator and found that the battery was not holding a charge.The fse replaced the main ventilator battery.The ventilator passed all testing and 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, the 840 ventilator generated a device alert and the safety valve opened indicating 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

Evaluation summary: one battery pack assembly was returned to medtronic for further analysis.The battery pack assembly terminal voltage measured at the connector was reading 25.8 v which is within the expected range.The battery was attached to the test ventilator and it successfully passed all tests and calibrations.The unit ran in battery mode for 1 hour, with no errors.Operating time for a new, fully charged battery is at least 60 minutes.This battery pack fell well short of 60 minutes operating time.The 840 ventilator system service manual, table 1-11: schedule of periodic maintenance states that the battery pack should be replaced every 2 years or as necessary.With a manufacture date of august 2016, this battery pack should have already been replaced as part of the preventative maintenance schedule.The cause of the observed condition was determined to be the depleted service life of the battery.The event will be included in monitoring.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, the 840 ventilator generated a device alert and the safety valve opened indicating 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.

• 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: 7575515
• MDR Text Key: 110343456
• Report Number: 8020893-2018-00252
• 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: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• 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: 05/20/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/1998
• 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