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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 Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that there were issues with the settings on the anesthesia system.There is no report of patient harm.Manufacturer´s reference number: (b)(4).
 
Manufacturer Narrative
Our field service engineer visited the hospital and the investigation showed that there was no fault with the machine, but instead a request to change the startup configuration so that the device would boot up and run in "prvc" instead of "volume control".
 
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 Key15233494
MDR Text Key303174764
Report Number8010042-2022-01409
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K191027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2022
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
Date Manufacturer Received09/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/26/2020
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
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