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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 Problems Crack (1135); Infusion or Flow Problem (2964)
Patient Problem No Patient Involvement (2645)
Event Date 03/06/2020
Event Type  Malfunction  
Manufacturer Narrative

A ge healthcare service representative performed a checkout of the equipment and confirmed the reported complaint. The adjustable pressure limiting valve was replaced, and the unit was returned to service. No report of patient involvement. Date of device manufacture year is 2004. The month of manufacture was unavailable at time of mdr filing.

 
Event Description

The hospital reported that the adjustable pressure limit valve knob was broken preventing manual ventilation. 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 Key9907696
MDR Text Key222157146
Report Number2112667-2020-01110
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK000706
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 03/31/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/31/2020
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 Received03/06/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/01/1970
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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