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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 Protective Measures Problem (3015)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/19/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that while in use on a patient, the anesthesia workstation generated alarms for high airway pressure.There was no patient harm.(b)(4).
 
Event Description
Manufacturer ref #: 1910mcc1011.
 
Manufacturer Narrative
The investigation into this matter consists of an evaluation of the received device logs only as the replaced oxygen gas module nozzle units (fresh gas and reflector modules) have not been available for investigation.The logs were received and show that successful system check outs were performed prior to and after the event indicating that no technical malfunctions were present.The received logs contain alarms for low fio2 and airway pressure:high.No technical errors in the tech log related to the reported event can be seen.Without having been able to investigate the replaced parts, we are unable to determine the true cause of the reported issues.
 
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Brand Name
FLOW-I C20
Type of Device
GAS-MACHINE, ANESTHESIA
Manufacturer (Section D)
MAQUET CRITICAL CARE AB
roentgenvagen 2
solna
MDR Report Key8416456
MDR Text Key138779723
Report Number8010042-2019-00155
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 distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 08/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2019
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
Date Manufacturer Received02/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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