• 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. AESTIVA 7900 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. AESTIVA 7900 ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Inaccurate Delivery (2339)
Patient Problem Low Oxygen Saturation (2477)
Event Date 07/12/2022
Event Type  Injury  
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 patient information provided. Legal manufacturer: (b)(4). Device evaluation anticipated, but not yet begun.
 
Event Description
The hospital reported a patient was connected to an aespire 7900 when the unit alarmed for low tidal volume. Reportedly, the patient desaturated and showed signs of hypoxia. The patient was switched to another anesthesia machine. There was no patient injury. Ge healthcare will submit a follow-up report when the investigation has been completed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAESTIVA 7900
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 Key15216269
MDR Text Key297767855
Report Number2112667-2022-02858
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,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 10/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2022
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 Received09/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/26/2014
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: 08/12/2022 Patient Sequence Number: 1
-
-