Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE FINLAND OY ADU; ANESTHESIA GAS MACHINE
  • 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
 

GE HEALTHCARE FINLAND OY ADU; ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Sticking (1597)
Patient Problem No Patient Involvement (2645)
Event Date 12/19/2016
Event Type  malfunction  
Manufacturer Narrative
During ge healthcare technician checkout it was noted that proportional valve and flow sensor were faulty.Replaced the proportional inspiratory valves and flow sensor to fix the reported issue.No report of patient involvement.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.
 
Event Description
The hospital reported that, during pre-use checkout, it was found that bellows were jammed.The unit didn't pass the pre-use checkout and automatic ventilation was not available.There was no reported patient involvement.
 
Manufacturer Narrative
Follow-up mdr filed so that event description could include information that device alarmed.Event problem code updated to indicate alarm subsequently added.
 
Event Description
The hospital reported that, during pre-use checkout, it was found that bellows were jammed.The unit didn't pass the pre-use checkout and automatic ventilation was not available.Unit also alarmed for the inspiratory flow sensor error.There was no reported patient involvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ADU
Type of Device
ANESTHESIA GAS MACHINE
Manufacturer (Section D)
GE HEALTHCARE FINLAND OY
kuortaneenkatu 2
helsinki
FI 
Manufacturer Contact
john szalinski
540 w. northwest highway
barrington, IL 
MDR Report Key6255835
MDR Text Key64911950
Report Number9610105-2017-00006
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K050676
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 01/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/19/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/1970
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
-
-