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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESPIRE 7100 ANESTHESIA GAS MACHINE

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DATEX-OHMEDA, INC. AESPIRE 7100 ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/10/2021
Event Type  malfunction  
Manufacturer Narrative
A ge healthcare service representative performed a checkout of the system and confirmed the reported issue. The soda lime container and condenser were cleaned to resolve 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. Legal manufacturer: (b)(4).
 
Event Description
The hospital reported low tidal volume caused by a large leak during a case. There was no report of patient injury.
 
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Brand NameAESPIRE 7100
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
MDR Report Key12592186
MDR Text Key275881209
Report Number2112667-2021-02270
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,Followup
Report Date 11/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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