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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
Catalog Number 6677200
Device Problem No Flow (2991)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/17/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the anesthesia failed to provide gas to the patient.There was no patient harm.(b)(4).
 
Manufacturer Narrative
It was reported that the anesthesia workstation failed to provide gas to the patient.No additional information surrounding the event has been provided.The device logs were received and the evaluation of the logs show that clinical alarms such as leakage, expiratory minute volume: low, respiratory rate: high indicates that leakages caused or contributed to the reported event.There were no generation of technical errors related to the event.The logs show that a successful system check out was performed prior to the event.Without any additional information or parts to investigate, we are unable to determine the true cause of the reported issues.
 
Event Description
Manufacturer ref #: (b)(4).Importer ref #: (b)(4).
 
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Brand Name
FLOW-I
Type of Device
GAS-MACHINE, ANESTHESIA
Manufacturer (Section D)
MAQUET CRITICAL CARE AB
solna
SW 
MDR Report Key8335290
MDR Text Key136502986
Report Number8010042-2019-00083
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
Type of Report Initial,Followup
Report Date 07/11/2019
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 Catalogue Number6677200
Was Device Available for Evaluation? No
Device AgeYR
Initial Date Manufacturer Received 01/17/2019
Initial Date FDA Received02/13/2019
Supplement Dates Manufacturer Received07/11/2019
Supplement Dates FDA Received07/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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