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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 Patient Involvement (2645)
Event Date 02/04/2021
Event Type  malfunction  
Event Description
It was reported that the leakage test failed during system check out.There was no patient involvement manufacturer´s ref #: (b)(4).
 
Manufacturer Narrative
The company field service engineer investigated the anesthesia workstation at the hospital and concluded that failure of the reported leakage test failure during system check out (sco) was caused by damaged o-rings in the water trap receptacle for the gas analyzer.The water trap receptacle including o-rings was replaced and the anesthesia workstation was returned to service, no parts have been returned for investigation and no device logs have been received.The cause of the reported sco failure was damaged o-rings in the water trap receptacle.
 
Event Description
Manufacturer's ref #: (b)(4).
 
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Brand Name
FLOW-I
Type of Device
GAS-MACHINE, ANESTHESIA
Manufacturer (Section D)
MAQUET CRITICAL CARE AB
roentgenvagen 2
solna
MDR Report Key11383866
MDR Text Key233739044
Report Number8010042-2021-00501
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K191027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
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
Initial Date Manufacturer Received 02/04/2021
Initial Date FDA Received02/26/2021
Supplement Dates Manufacturer Received06/14/2021
Supplement Dates FDA Received06/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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