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

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. 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
 

DATEX-OHMEDA, INC. CARESTATION 650 A1 ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Computer Operating System Problem (2898)
Patient Problem No Patient Involvement (2645)
Event Date 09/12/2018
Event Type  malfunction  
Manufacturer Narrative
Ge healthcare investigation into the reported occurrence is ongoing. A follow-up report will be issued when the investigation has been completed. 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. Device evaluation anticipated, but not yet begun.
 
Event Description
The hospital reported a n2o mixer hardware failure during system checkout. There was no report of patient involvement.
 
Manufacturer Narrative
Additional information was received stating that this failure would not allow a hypoxic delivery to the patient. This was not a reportable malfunction. Additional information was received stating that this failure would not allow a hypoxic delivery to the patient. This was not a reportable malfunction.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCARESTATION 650 A1
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer Contact
john szalinski
3000 n grandview blvd.
waukesha, WI 
MDR Report Key7956384
MDR Text Key123396711
Report Number2112667-2018-02005
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,Followup
Report Date 11/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/16/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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

-
-