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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Information (3190)
Event Date 05/20/2020
Event Type  Injury  
Event Description

It was reported that the anesthesia workstation was used during an emergency trach. Procedure and the patient coded during the procedure. The patient was put on a ventilator after. The patient final outcome is unknown. 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 Key10161256
MDR Text Key195366768
Report Number8010042-2020-00366
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
PMA/PMN NumberK191027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 06/17/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/17/2020
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
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/21/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/07/2020
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 06/17/2020 Patient Sequence Number: 1
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