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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESTIVA 7100 ANESTHESIA GAS MACHINE

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DATEX-OHMEDA, INC. AESTIVA 7100 ANESTHESIA GAS MACHINE Back to Search Results
Model Number 1006-9320-000
Device Problem Improper Flow or Infusion (2954)
Patient Problem Pulmonary Edema (2020)
Event Date 05/19/2021
Event Type  Injury  
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. Weight, ethnicity, race: not available. Device evaluation anticipated, but not yet begun.
 
Event Description
The hospital reported the adjustable pressure limit (apl) valve stuck open during a case causing high positive end-expiratory pressure (peep). The case was completed in bag mode, with the clinician removing the bag to relieve pressure build-up. Subsequently, the patient was extubated earlier than planned. It was reported that the patient suffered pulmonary edema and laryngospasm and was admitted to the med surg floor on bi-level positive airway pressure. The patient was later discharged with no injury.
 
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Brand NameAESTIVA 7100
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
MDR Report Key12068428
MDR Text Key259331439
Report Number2112667-2021-01617
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K172045
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup,Followup
Report Date 10/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1006-9320-000
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/22/2005
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: 06/25/2021 Patient Sequence Number: 1
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