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

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) CARESTATION 650 A1 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 MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) CARESTATION 650 A1 ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Suction Problem (2170)
Patient Problem No Patient Involvement (2645)
Event Date 10/09/2018
Event Type  malfunction  
Manufacturer Narrative
A ge healthcare service representative performed a checkout of the system and confirmed the reported issue. The suction tubing was re-routed to remove a kink which resolved the reported issue. No report of patient involvement. (b)(4). 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 the suction was not working properly. There was no report of patient involvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCARESTATION 650 A1
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI)
no. 19 changjiang road
national hi-tech dev. zone
wuxi 21402 8
CH 214028
Manufacturer Contact
john szalinski
3000 n grandview blvd.
waukesha, WI 
MDR Report Key8030311
MDR Text Key126663409
Report Number9710602-2018-00283
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K151570
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial
Report Date 11/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/09/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/02/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-