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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 Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Gas/Air Leak (2946)
Patient Problem No Patient Involvement (2645)
Event Date 05/19/2020
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. The distributor performed a checkout of the equipment and confirmed the reported complaint. The field engineer reinstalled the soda lime canister and cleaned the breathing system to resolve the issue.
 
Event Description
The hospital reported that the tidal volume was not being achieved due to a leak greater than 4. 5 lpm. There was no report of patient involvement.
 
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Brand NameAESPIRE 7100
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer Contact
john szalinski
3000 n grandview blvd.
waukesha, WI 
MDR Report Key10143514
MDR Text Key194807624
Report Number2112667-2020-01695
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K000706
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial
Report Date 06/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/19/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/26/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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