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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 02/12/2021
Event Type  Malfunction  
Manufacturer Narrative

Device evaluation summary: medtronic conducted an investigation based upon all information received. The device was available for evaluation. The medtronic field service engineer replaced the piezo alarm and breath delivery (bd) alarm cable. All testing passed per manufacturer specifications at the time of service. It was reported that during installation by a medtronic field service engineer, the 980 ventilator breath delivery (bd) piezo alarm did not sound. The piezo alarm and bd alarm cable were returned to medtronic for further evaluation. The bd alarm cable was tested and performed as designed. The piezo alarm was installed in a test ventilator and powered on in service mode, without issue. The extended self test breath delivery audio test was performed and the alarm failed to annunciate. The reported issue was confirmed. The most likely cause was the piezo alarm. The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality specifications. If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that during installation by a medtronic field service engineer, the 980 ventilator breath delivery (bd) piezo alarm did not sound. The ventilator was not in use on a patient at the time of the event.

 
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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 avenue
carlsbad, CA 92008
7606035046
MDR Report Key11507933
MDR Text Key240443961
Report Number8020893-2021-00043
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
Report Date 03/17/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/17/2021
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? Device Returned To Manufacturer
Date Returned to Manufacturer03/02/2021
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/06/2020
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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