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

Model Number 840

Device Problem Defective Alarm (1014)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) verified the reported issue.The fse found that the ventilator's gui went blank and the alarm lights blinked on and off.The ventilator logged the following diagnostic code.The fse replaced power supply to resolve the issue.The ventilator has passed calibrations, performance verification testing (pvt), extended self test (est), and short self test (sst) and is ready for use.The ventilator has been returned to the customer.If the replaced part is returned for failure investigation, a supplement 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.

Event Description

It was reported that the 840 ventilator generated background fault error code and became inoperative.During inspection by the field service engineer, the 840 ventilator had a (graphic user interface) visual alarm failure.The ventilator was not in use on a patient at the time of the reported event.

Manufacturer Narrative

Device evaluation summary: the tamura (taiyo yuden) power supply was returned for failure investigation.The part was visually inspected and functionally tested with no anomalies observed.Conclusion: 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: 7818675
• MDR Text Key: 118305644
• Report Number: 8020893-2018-00397
• Device Sequence Number: 1
• Product Code: CBK
• 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: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• 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-NPB840-DS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2004
• 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