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U.S. Department of Health and Human Services

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

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DATEX-OHMEDA, INC. AISYS; ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Suction Failure (4039)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/28/2022
Event Type  malfunction  
Manufacturer Narrative
Ge healthcare investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.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).
 
Event Description
It was reported that there was a malfunction resulting in loss of suction.There was no patient involvement.
 
Manufacturer Narrative
The customer declined ge service.No repair information available.
 
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Brand Name
AISYS
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
3030 ohmeda dr,
madison, WI 53718
MDR Report Key15851817
MDR Text Key307686794
Report Number2112667-2022-04965
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K172045
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 12/22/2022
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/28/2022
Initial Date FDA Received11/23/2022
Supplement Dates Manufacturer Received12/07/2022
Supplement Dates FDA Received12/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/16/2011
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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