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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 Output Problem (3005)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/26/2020
Event Type  malfunction  
Event Description
It was reported that a leakage from the breathing circuit ocurred during patient treatment.There was no patient harm.Manufacturer's reference number: 404269.
 
Manufacturer Narrative
Investigation of the reported event has been completed.No parts have been returned for the further analysis of the issue and no picture of the broken part was received.Root cause of the reported failure has not been determined.
 
Event Description
Manufacturer's reference number: (b)(4).
 
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Brand Name
FLOW-I
Type of Device
GAS-MACHINE, ANESTHESIA
Manufacturer (Section D)
MAQUET CRITICAL CARE AB
roentgenvagen 2
solna
Manufacturer (Section G)
MAQUET CRITICAL CARE AB
roentgenvagen 2
solna
Manufacturer Contact
caroline kabbabe
roentgenvagen 2
solna 
MDR Report Key11139068
MDR Text Key225746683
Report Number8010042-2021-00017
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K191027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2021
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
Date Manufacturer Received03/02/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
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