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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESTIVA MRI ANESTHESIA GAS MACHINE

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DATEX-OHMEDA, INC. AESTIVA MRI ANESTHESIA GAS MACHINE Back to Search Results
Model Number 1006-9310-000
Device Problem Improper Flow or Infusion (2954)
Patient Problem Low Oxygen Saturation (2477)
Event Date 12/22/2021
Event Type  Injury  
Event Description
Per medwatch report # mw5109273: "following intubation and prior to start of surgery in the ep lab, the ge aestiva anesthesia machine was unable to manually ventilate patient in the bag mode. Bag was distended but no chest rise observed when squeezed. Pt spo2 values decreased for period of 4 minutes, until machine was able to ventilate in mechanical ventilation mode. The intervention required to prevent permanent impairment/ damage at this point is that an ambu-bag had to be used to deliver oxygen to the pt. Next, the machine was reconnected to the pt, and successfully ventilated the pt. In mechanical ventilation mode. The other serious or important medical event was that the procedure was cancelled as a result of the desaturation event. Pt was not found to have sustained any neurological damage as a result of event, was discharged from hospital, and procedure was successfully performed 10 days later. " ge healthcare will submit a follow-up report when the investigation has been completed.
 
Manufacturer Narrative
Ge healthcare investigation into the reported occurrence is ongoing. A follow-up report will be issued when the investigation has been completed. Ethnicity and race: information not available. Legal manufacturer: (b)(4). Device evaluation anticipated, but not yet begun.
 
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Brand NameAESTIVA MRI
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 Key14712230
MDR Text Key294132121
Report Number2112667-2022-01624
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172045
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 08/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1006-9310-000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/02/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/15/2006
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: 06/16/2022 Patient Sequence Number: 1
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