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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
Model Number 1009-9000-000
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/10/2020
Event Type  Malfunction  
Manufacturer Narrative

Ethnicity and race not available. Date of device manufacture year is 2005x. The month of manufacture was unavailable at time of mdr filing. A ge healthcare service representative performed a checkout of the system and confirmed the reported issue. The flow sensors were replaced to resolve the reported issue.

 
Event Description

The hospital reported a malfunction resulting in a leak greater than 4. 5 lpm. 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
Manufacturer Contact
john szalinski
MDR Report Key10671888
MDR Text Key213034404
Report Number2112667-2020-02828
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK172045
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 10/13/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/13/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1009-9000-000
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/14/2020
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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