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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 Low Oxygen Saturation (2477)
Event Date 03/06/2024
Event Type  Injury  
Event Description
It was reported that during patient treatment, while switching from manual ventilation mode to automatic ventilation mode, the anesthesia system did not switch straight away.The patient's saturation level was decreasing and they switched back to manual ventilation mode again.Final patient outcome was no injury.Mfg.(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 Key19034244
MDR Text Key339268416
Report Number3013876692-2024-00020
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 Distributor
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/03/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
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
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/03/2024
Distributor Facility Aware Date03/07/2024
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer04/03/2024
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/03/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/31/2020
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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