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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 05/20/2022
Event Type  malfunction  
Event Description
The hospital reported a system shutdown during pre-use checkout that resulted in a loss of mechanical ventilation.There was no patient involvement.
 
Manufacturer Narrative
The distributor performed a checkout of the equipment and confirmed the reported complaint.The vent engine to display cable was reseated to resolve the issue.No report of patient involvement.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Legal manufacturer: (b)(4).
 
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Brand Name
AESTIVA 7100
Type of Device
ANESTHESIA 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
MDR Report Key14713224
MDR Text Key302710599
Report Number2112667-2022-01630
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 06/16/2022
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? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/20/2022
Date Device Manufactured06/02/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
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