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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 Sticking (1597)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/08/2018
Event Type  malfunction  
Event Description
It was reported that inspiratory and expiratory valves in the patient cassette were stuck in closed position during patient treatment.There was no patient harm.(b)(4).
 
Manufacturer Narrative
The returned patient cassette including the allegedly stuck one way valves has been tested and there were no indications of stuck valves.The patient cassette functions as intended.According to the test log, a successful system check out (sco) was performed just prior to the event.There is no recorded sco after the event.Both the trend log and the internal log show that there were difficulties to ventilate the patient.There were alarms indicating a leakage.Based on the lack of technical alarms related to pressure and the lack of negative pressures recorded in the trend log, it is not likely that a stuck inspiratory and/or inspiratory valve contributed to the reported event.Based of the above information, we are unable to determine the root-cause of the reported problem.(b)(4).
 
Event Description
Manufacturer's ref #: (b)(4).
 
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Brand Name
FLOW-I C20
Type of Device
GAS-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 Key7342876
MDR Text Key102747683
Report Number8010042-2018-00143
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K160665
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,Followup
Report Date 04/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberC20
Device Catalogue Number6677200
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/09/2018
Date Device Manufactured03/30/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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