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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESTIVA 7900; ANESTHESIA GAS MACHINE

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DATEX-OHMEDA, INC. AESTIVA 7900; ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/31/2022
Event Type  malfunction  
Event Description
It was reported that there was a malfunction resulting in loss of mechanical ventilation during pre-use checkout.There was no patient involvement.
 
Manufacturer Narrative
The distributor performed a checkout of the equipment and confirmed the reported complaint.The flow sensor was calibrated 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: hcs madison - (b)(4).
 
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Brand Name
AESTIVA 7900
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 Key15503504
MDR Text Key301162069
Report Number2112667-2022-03788
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 09/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 08/31/2022
Initial Date FDA Received09/29/2022
Date Device Manufactured02/18/2010
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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