MAUDE Adverse Event Report: COVIDIEN 980 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 980

Device Problem Defective Alarm (1014)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) evaluated the device and replaced the breath delivery (bd) power control / distribution board.The ventilator passed all testing per manufacturing specification and was placed back into clinical use.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 a 980 ventilator failed the breath delivery unit (bdu) alarm test of the extended self test (est).The alarm did not sound.The ventilator was not in use on a patient at the time of the reported event.

Manufacturer Narrative

Device evaluation summary: the breath delivery (bd) power board / distribution board was returned for failure investigation.Both parts were visually inspected with no anomalies observed.The bd power distribution board was functionally tested with no malfunction or product deficiency identified.The bd power controller was installed into a test ventilator for analysis.The ventilator powered on with no errors, alerts, alarms, or other issues.Calibration was successfully completed.The extended self test (est) bd audio test was run 10 times, with the following results: - the first attempt failed with error message "power - fail cap not discharging" generating no sound and no prompt to confirm the presence of the alarm.- the next 9 attempts failed with "piezo alarm failure" generating no sound and a prompt to confirm the present of the alarm.A complete est was then run, passing all tests except the bd audio, which generated the same failures as the initial attempts.Sst (short self-test) was locked out due to the failure during est.The reported event that ventilator failed the bd audio portion of est was duplicated.The probable cause of the reported failure is a faulty c4 capacitor on the power controller pcba.Despite the ¿piezo alarm failure¿ error codes, the piezo alarm was confirmed to be functioning both before and after testing the returned boards.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 980 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 ; 15 hampshire street; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 7927404
• MDR Text Key: 122458723
• Report Number: 8020893-2018-00486
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521172524
• UDI-Public: 10884521172524
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162738
• 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: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 980
• Device Catalogue Number: 980X3ENDIUU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2014
• 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