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

Device evaluation summary: the service engineer reported that there was no voltage measured to the bd piezo alarm during testing.The device has not been repaired.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that, during preventative maintenance, a 980 ventilator failed the breath delivery (bd) audio test on an extended self test (est).The ventilator was not in use on a patient at the time of the reported event.

Manufacturer Narrative

Correction to h2 evaluation code result.Device evaluation summary: the service engineer (se) inspected the device and replaced the breath delivery (bd) power distribution/power controller printed circuit board (pcb).The se found the device generating a serial number mismatch.The se replaced the line interface pcb and the communications backplane pcb.The ventilator passed all testing per manufacturing specification and was placed back into clinical use.If the replaced parts are 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.

Manufacturer Narrative

Device evaluation summary: the following components were returned for failure investigation.1.Breath deliver (bd) power controller/ bd power distribution printed circuit board (pcb) 2.Line interface pcb 3.Communications backplane pcb all parts were visually inspected with no visible distortion or damage observed that may have affected the function of the board.The communications backplane pcb and the line interface pcb were functionally tested with no anomalies observed.There was no fault found.The bd power controller and the bd power distribution pcbs were functionally tested.The reported event that ventilator failed the bd audio portion of the extended self test was duplicated.Based on the failure of the piezo alarm to charge, the probable cause of the reported failure is a faulty c4 capacitor on the power controller pcba.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; michael collins road mervue; galway
• Manufacturer (Section G): COVIDIEN; michael collins road mervue; galway
• Manufacturer Contact: kelly adams ; 2101 faraday ave.; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 7850642
• MDR Text Key: 119492386
• Report Number: 8020893-2018-00430
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521171541
• UDI-Public: 10884521171541
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• 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: 980X1ENDIUU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2015
• 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