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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C20 GAS-MACHINE, ANESTHESIA

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MAQUET CRITICAL CARE AB FLOW-I C20 GAS-MACHINE, ANESTHESIA Back to Search Results
Model Number C20
Device Problem Defective Component (2292)
Patient Problem No Patient Involvement (2645)
Event Date 09/17/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that it was not possible to generate vacuum with the auxiliary o2 and suction unit. The control knob for regulation of vacuum had become inoperable. There was no patient connected to the anesthesia workstation at the time of the event. (b)(4).
 
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Brand NameFLOW-I C20
Type of DeviceGAS-MACHINE, ANESTHESIA
Manufacturer (Section D)
MAQUET CRITICAL CARE AB
solna
SW
Manufacturer (Section G)
MAGNUS LINDQVIST
maquet critical care ab
röntgenvägen 2, se-171 54
solna
SW
Manufacturer Contact
maquet critical care ab
röntgenvägen 2, se-171 54
solna 
MDR Report Key7918848
MDR Text Key122457888
Report Number8010042-2018-00510
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K160665
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,Followup
Report Date 02/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberC20
Device Catalogue Number6677200
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received09/17/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/18/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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