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U.S. Department of Health and Human Services

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

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COVIDIEN 840 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
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.

 
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Brand Name840 VENTILATOR
Type of DeviceVENTILATOR, 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 avenue
carlsbad, CA 92008
7606035046
MDR Report Key10268179
MDR Text Key199566599
Report Number8020893-2020-00101
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeBE
PMA/PMN NumberK970460
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received07/13/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number4-840220NISC-EN
Device Catalogue Number4-840220NISC-EN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/19/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/01/2000
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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