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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I GAS-MACHINE, ANESTHESIA

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MAQUET CRITICAL CARE AB FLOW-I GAS-MACHINE, ANESTHESIA Back to Search Results
Model Number FLOW-I C20
Device Problem Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 11/24/2019
Event Type  Malfunction  
Event Description

It was reported that the o2 flush test and the afgo valve test failed during system check out. There was no patient connected to the anesthesia workstation at the time of the event. Manufacturer´s ref #: (b)(4).

 
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Brand NameFLOW-I
Type of DeviceGAS-MACHINE, ANESTHESIA
Manufacturer (Section D)
MAQUET CRITICAL CARE AB
roentgenvagen 2
solna
Manufacturer (Section G)
MAQUET CRITICAL CARE AB
roentgenvagen 2
röntgenvägen 2, se-171 54
solna
Manufacturer Contact
sara soderholm roman
roentgenvagen 2
röntgenvägen 2, se-171 54
solna 
MDR Report Key9457596
MDR Text Key179149149
Report Number8010042-2019-00896
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
Reporter Country CodeFI
PMA/PMN NumberK160665
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,Followup
Report Date 06/16/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/12/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberFLOW-I C20
Device Catalogue Number6677200
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 Received06/15/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/03/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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