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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 Suction Problem (2170)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/04/2019
Event Type  malfunction  
Event Description
It was reported that the auxiliary o2 and suction module, attached to the anesthesia workstation, was making noises and suction was very weak. There was no patient harm. Manufacturer reference #: (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
solna
Manufacturer Contact
sara soderholm roman
roentgenvagen 2
solna 
MDR Report Key8878256
MDR Text Key153826430
Report Number8010042-2019-00581
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
K160665
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFLOW-I C20
Device Catalogue Number6677200
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/15/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/08/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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