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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 Consequences Or Impact To Patient (2199)
Event Date 02/09/2021
Event Type  malfunction  
Event Description
It was reported that several alarms for leakage were generated during treatment. The logs show alarms for high airway pressure. There was no patient harm. Manufacturer's 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 Key11372413
MDR Text Key233285452
Report Number8010042-2021-00480
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K191027
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
Report Date 02/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2021
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/09/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/17/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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