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

Model Number 980

Device Problem Defective Alarm (1014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Medtronic has not received the suspect device from the customer for evaluation nor has the device been evaluated by the service engineer.The customer moved the ventilator to another room and the ventilator functioned normally.The ventilator was not made available to the field service engineer.A regional ventilator product specialist has been referred for further training as this may be a settings issue.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that, while in use on a patient, a 980 ventilator had a red flashing alarm with no audio alarm.The patient was not removed from the ventilator as it continued to ventilate the patient.The patient was not harmed or injured as a result of the reported event.

• 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 ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 8228800
• MDR Text Key: 132498528
• Report Number: 8020893-2019-00007
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/22/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1