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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AVANCE CS2 ANESTHESIA GAS MACHINE

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DATEX-OHMEDA, INC. AVANCE CS2 ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Improper Flow or Infusion (2954)
Patient Problem Low Blood Pressure/ Hypotension (1914)
Event Date 04/28/2022
Event Type  Injury  
Event Description
The hospital reported a patient connected to an avance cs2 had a sudden drop in blood pressure at 5:58. Resuscitation measures were given. At 6:00, it was determined that the bellows of the avance cs2 were not being supplied with air. The avance cs2 was restarted, normal ventilation resumed, and patient recovered. Ge healthcare will submit a follow-up report when the investigation has been completed.
 
Manufacturer Narrative
Ge healthcare's investigation into the reported occurrence is ongoing. A follow-up report will be issued when the investigation has been completed. No patient information is available. Legal manufacturer: (b)(4). Device evaluation anticipated, but not yet begun.
 
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Brand NameAVANCE CS2
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer (Section G)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer Contact
anthony amenson
3030 ohmeda drive
madison, WI 53718
MDR Report Key14592807
MDR Text Key293268449
Report Number2112667-2022-01388
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K172045
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 10/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/08/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/03/2022 Patient Sequence Number: 1
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