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

Model Number 980

Device Problems Defective Alarm (1014); Display or Visual Feedback Problem (1184)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The service engineer (se) inspected the device and installed a breath delivery (bd) power control pcba (printed circuit board assembly).The ventilator passed all testing per manufacturing specification and was placed back into clinical use.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 was unable to pass the breath delivery (bd) audio test and alarmed with an error code.The ventilator was not in use on a patient at the time of the reported event.

Manufacturer Narrative

The following part was returned for failure investigation: breath delivery (bd) power controller printed circuit board assembly (pcba).The bd power controller pcba was visually inspected and showed no anomalies.The bd power controller pcba was functionally tested and during an extended self test (est), the ventilator failed the ¿bd audio test¿.The alarm audible tone was low and the "bd audio test" failed for "power fail cap not discharging".The fault was isolated to the capacitor.Conclusion: electronic component failure.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: 7721180
• MDR Text Key: 115273917
• Report Number: 8020893-2018-00334
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521171138
• UDI-Public: 10884521171138
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K162738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018

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: 980
• Device Catalogue Number: 980U1ENDICU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/19/2018
• Initial Date FDA Received: 07/25/2018
• Supplement Dates Manufacturer Received: 09/26/2018; 08/08/2018
• Supplement Dates FDA Received: 10/01/2018; 10/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2014
• 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