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U.S. Department of Health and Human Services

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

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COVIDIEN 980 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 980X3ENDIUU
Device Problem Defective Alarm (1014)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/04/2020
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, the 980 ventilator had an ¿active 360 alarm¿ with no audio or visual alarm on the screen. There was no harm or injury to the patient as a result of the event. Although requested, information pertaining to patient intervention has not been provided.

 
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Brand Name980 VENTILATOR
Type of DeviceVENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
COVIDIEN
micheal collins rd mervue
galway
EI
Manufacturer (Section G)
COVIDIEN
micheal collins rd mervue
galway
EI
Manufacturer Contact
kelly adams
2101 faraday ave
carlsbad, CA 92008
7606035046
MDR Report Key10920479
MDR Text Key218720357
Report Number8020893-2020-00189
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK131252
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/19/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/30/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number980X3ENDIUU
Device Catalogue Number980X3ENDIUU
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/22/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/08/2018
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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