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

Model Number 980

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 05/12/2018

Event Type  malfunction  

Manufacturer Narrative

Covidien/medtronic has not received the device component from the customer nor has the field service engineer evaluated the venitlator.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 generated a background fault alarm and a ¿device inoperative ¿ message which indicates a loss of ventilation.The patient was removed from the ventilator and manually ventilated before being placed on an alternate ventilator.The patient was not harmed or injured as a result of the reported event.

Manufacturer Narrative

The graphical user interface printed circuit board and the user interface printed circuit board were returned for failure investigation.The parts were visually inspected and functionally tested with no anomalies observed.No fault found.There was no malfunction or product deficiency identified.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 ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 7571757
• MDR Text Key: 110170442
• Report Number: 8020893-2018-00249
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521171558
• UDI-Public: 10884521171558
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K162738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• 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: 980X1JADIJJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2014
• 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