MAUDE Adverse Event Report: COVIDIEN 840 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 4-840220NISC-EN

Device Problem No Flow (2991)

Patient Problems High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)

Event Date 06/17/2020

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, an 840 ventilator generated a high volume alarm, red screen and the unit stopped ventilating the patient.After the ventilator was rebooted, it was still not working.The patient was removed from the ventilator, manually ventilated and placed on an alternate ventilator.The patient experienced tachycardia (90 beats per minute), hypertension followed by hypotension which was treated with noradrenaline.The patient returned to baseline within 30 minutes.

• Brand Name: 840 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway ; IE
• Manufacturer (Section G): COVIDIEN; micheal collins rd mervue; galway ; IE
• Manufacturer Contact: kelly adams ; 2101 faraday avenue; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 10268179
• MDR Text Key: 199566599
• Report Number: 8020893-2020-00101
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521077218
• UDI-Public: 10884521077218
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K970460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4-840220NISC-EN
• Device Catalogue Number: 4-840220NISC-EN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2000
• 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
• Patient Age: 78 YR
• Patient Weight: 95