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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESPIRE 7900; ANESTHESIA GAS MACHINE
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DATEX-OHMEDA, INC. AESPIRE 7900; ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/23/2021
Event Type  malfunction  
Manufacturer Narrative
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.A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The flow sensors were ordered for replacement to resolve the issue.
 
Event Description
The hospital reported that the diaphragm of the flow sensor was stuck open.There was no report of patient involvement.
 
Manufacturer Narrative
Additional information was received that the flow sensor did not get suck.There was no loss of ventilation and no reportable malfunction.Unit continues to ventilate and alarms remain functional.H3 other text: additional information was received that the flow sensor did not get suck.There was no loss of ventilation and no reportable malfunction.Unit continues to ventilate and alarms remain functional.
 
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Brand Name
AESPIRE 7900
Type of Device
ANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
MDR Report Key12210646
MDR Text Key265139488
Report Number2112667-2021-01747
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 foreign,health professional,u
Type of Report Initial,Followup
Report Date 07/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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