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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 Energy Output Problem (1431)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/03/2020
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. A ge healthcare service representative performed a checkout of the system. Review of the logs did not confirm the reported issue. The bag to vent switch was replaced and system performed normally.

 
Event Description

The hospital reported that the bellows did not work and unit would not ventilate. There was no report of patient involvement.

 
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Brand NameAESPIRE 7900
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 Key10609726
MDR Text Key214826318
Report Number2112667-2020-02734
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
PMA/PMN NumberK172045
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Type of Report Initial
Report Date 09/30/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/30/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/03/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/14/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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