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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
Device Problem Unexpected Shutdown (4019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/26/2022
Event Type  malfunction  
Manufacturer Narrative
The distributor performed a checkout of the equipment and confirmed the reported complaint. The carrier board was recommended for replacement to resolve the issue. A ge healthcare service representative performed a checkout of the system but did not confirm the reported issue. Patient information could not be obtained due to country privacy laws. The initial reporter is located outside the u. S. , and therefore this information is not provided due to country privacy laws. Unique identifier: (b)(4). Legal manufacturer: (b)(4).
 
Event Description
The hospital reported a system shutdown that resulted in in a loss of mechanical ventilation. There was no patient involvement.
 
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Brand NameAESTIVA 7100
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 Key15276646
MDR Text Key302027437
Report Number2112667-2022-03005
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K172045
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 08/23/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/26/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/15/2002
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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