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

Model Number 980

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2018

Event Type  malfunction  

Manufacturer Narrative

Medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the service engineer.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 went into back up ventilation and the screen went black, generated error codes and had a leak.Reportedly, this is the second time a similar issue on this ventilator has happened.Reportedly, an extended self test (est) was performed by the customer and passed with the ventilator appearing "to be working fine after they ran est." although requested, information pertaining to patient intervention (if applicable) has not been provided.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; 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: 7665306
• MDR Text Key: 113283871
• Report Number: 8020893-2018-00307
• 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: K162738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• 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: 980X3ENDIUU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/29/2017
• 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