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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 Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/20/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the anesthesia workstation failed the safety valve test during system check out.There was no patient connected to the workstation at the time.(b)(4).
 
Event Description
Manufacturer ref #: (b)(4).Importer ref #: (b)(4).
 
Manufacturer Narrative
Getinge usa sales, llc (importer) is submitting this report on behalf of maquet critical care ab (manufacturer).Ref.Exemption #: e2018003 (b)(4).The anesthesia workstation was investigated on site by our company representative.The double channel plate was found with a missing gasket which caused the reported event.The double channel plate was replaced and after successful testing, the anesthesia workstation was returned to clinical use.The replaced double channel plate which consists of several gaskets was not returned for investigation.We have not received information stating which one of the gaskets that was missing.The logs from the anesthesia workstation were not received.We have not been able to determine why/when the gasket came loose.
 
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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 Key8335288
MDR Text Key136497280
Report Number8010042-2019-00082
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 06/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2019
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
Date Manufacturer Received06/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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