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

Model Number 980X3ENDIUU

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: medtronic service personnel (sp) inspected the ventilator and was unable to duplicate the reported issue.The ventilator passed all test and calibrations per manufacturer specifications at the time of service and was returned to the customer.From the logs provided and reviewed, it was confirmed while connected to wall/ac power, there was a temporary loss of followed by a resumption of ventilation.The logs indicated the loss of ventilation was caused by a total loss of power with no indication of a ventilator malfunction.With the information made available, a likely cause could not be determined.An internal investigation has been opened to address this 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 was ¿turning on and off by itself." there was no injury to the patient as a result of the event.Although requested, information pertaining to patient intervention has not been provided.

• Brand Name: 980 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; michael collins rd mervue; galway,ie ; IE
• Manufacturer (Section G): COVIDIEN; michael collins rd mervue; galway,ie ; IE
• Manufacturer Contact: kelly adams ; 2101 faraday avenue; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 10474994
• MDR Text Key: 213505696
• Report Number: 8020893-2020-00137
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521172524
• UDI-Public: 10884521172524
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131252
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 980X3ENDIUU
• Device Catalogue Number: 980X3ENDIUU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Date Manufacturer Received: 08/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2018
• 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