• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I GAS-MACHINE, ANESTHESIA

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAQUET CRITICAL CARE AB FLOW-I GAS-MACHINE, ANESTHESIA Back to Search Results
Model Number FLOW-I C20
Device Problem Device Handling Problem (3265)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/22/2020
Event Type  Malfunction  
Manufacturer Narrative

It was reported that a successful leakage test was performed before the case start but in some way, the breathing circuit after the test had been incorrectly connected. There are clinical alarms that are likely to have been caused by the inspiratory limb being connected to the afgo outlet instead of the patient cassette. There are no recordings in the technical log which suggests that there were any device malfunctions during the event. The connections to the inspiratory outlet, expiratory inlet and the afgo port on the anesthesia workstation are clearly marked with text and symbols to show where to connect the breathing circuit tubes. The different symbols are also described in the user¿s manual. This failure will be detected during system checkout if the breathing circuit tubes are incorrectly connected during the test. Our conclusion is that the cause of the reported issue was user error.

 
Event Description

It was reported that while in use on a patient, in the beginning of the case, the staff noticed that the inspiratory limb of the patient circuit had been applied to the afgo outlet at some point. There was no patient harm. (b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFLOW-I
Type of DeviceGAS-MACHINE, ANESTHESIA
Manufacturer (Section D)
MAQUET CRITICAL CARE AB
roentgenvagen 2
solna
Manufacturer (Section G)
MAQUET CRITICAL CARE AB
roentgenvagen 2
solna
Manufacturer Contact
sara soderholm roman
roentgenvagen 2
solna 
MDR Report Key10256833
MDR Text Key198323434
Report Number8010042-2020-00423
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
PMA/PMN NumberK191027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 07/10/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/10/2020
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
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/06/2020
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-