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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN PURITAN BENNETT VENTILATOR, CONTINUOUS, FACILITY USE

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COVIDIEN PURITAN BENNETT VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number G-760220DIUA-EN
Device Problem Defective Alarm (1014)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/06/2021
Event Type  Malfunction  
Manufacturer Narrative

Reported by the (b)(6) fda. It was reported that the hospital staff (engineer) inspected the unit. The engineer confirmed the reported issue and found that the printed circuit board (pcb) was faulty. If information is provided in the future, a supplemental report will be issued. 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, this 760 ventilator was generating a warning message but there was no alarm sound. The patient was removed from the ventilator and placed on an alternate ventilator without harm.

 
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Brand NamePURITAN BENNETT
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 Key11619603
MDR Text Key243956639
Report Number8020893-2021-00050
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK984379
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 04/06/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/06/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG-760220DIUA-EN
Device Catalogue NumberG-760220DIUA-EN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured08/05/2009
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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