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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C30; GAS-MACHINE, ANESTHESIA
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MAQUET CRITICAL CARE AB FLOW-I C30; GAS-MACHINE, ANESTHESIA Back to Search Results
Model Number C30
Device Problem High Readings (2459)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the anesthesia workstation measured a higher fico2 level than expected during an unknown time period.There was no patient harm.(b)(4).
 
Event Description
Manufacturer's ref #:(b)(4).
 
Manufacturer Narrative
Getinge usa sales, llc (importer) is submitting this report on behalf of maquet critical care ab (manufacturer).Ref.Exemption #: (b)(4).Getinge usa sales, llc (b)(4).Contact peron: (b)(6).The investigation into this matter consists of an evaluation of the received device logs only as no parts have been reported as replaced.The received logs does not confirm the reported issue with high fico2 readings as the reported date of event is not covered by the logs.There are no failing tests or clinical alarms in the supplied logs that suggests any device malfunction.We have not been able to determine the true cause of the reported issue.
 
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Brand Name
FLOW-I C30
Type of Device
GAS-MACHINE, ANESTHESIA
Manufacturer (Section D)
MAQUET CRITICAL CARE AB
solna
SW 
MDR Report Key8105703
MDR Text Key128599147
Report Number8010042-2018-00632
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 foreign,health professional,u
Type of Report Initial,Followup
Report Date 05/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberC30
Device Catalogue Number6677300
Was Device Available for Evaluation? No
Date Manufacturer Received05/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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