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 Date 09/28/2018

Event Type  malfunction  

Manufacturer Narrative

The service engineer (se) inspected the device and found the power controller board was faulty as it was not driving the alarm when ac (alternate current) power was disconnected.The se replaced the power controller board assembly (pcba).The se update the software to the current revision.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 supplemental 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 battery had an issue charging.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) distribution printed circuit board (pcb) 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.The bd power controller pcb was returned for failure investigation.A visual inspection of the returned part was conducted and no anomalies were observed.The part was attached to a failure investigation test ventilator for analysis.The ventilator was powered up normally and no errors were recorded in the diagnostic logs.Calibration tests were run successfully without any errors.The ventilator failed the extended self test bd audio test with "power fail cap not discharging" message displayed on the screen and an error showing in the diagnostic logs.The fault was isolated to the c4 super-capacitor device.The pb980 breath delivery unit contains a back-up alarm that will sound in the event of a total power loss (mains and battery).This alarm is powered by super-capacitor c4, and is operationally tested as part of the extended self test (est).A failure of this device would be detected during est.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received as follows: the ventilator is a demonstration unit used by the distributor for training purposes.The ventilator has never been on a patient.

• 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: 8065869
• MDR Text Key: 127071473
• Report Number: 8020893-2018-00543
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521171749
• UDI-Public: 10884521171749
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K162738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• 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: 980X1ENNISB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2014
• 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