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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 Appropriate Term/Code Not Available (3191)
Patient Problem Death (1802)
Event Date 02/24/2020
Event Type  Death  
Manufacturer Narrative
Ge healthcare's investigation into the reported occurrence is complete. There was no allegation of the device malfunctioning and the customer wanted ge to check out the device. The ge representative went onsite and performed operational checks and found the device to perform to specifications.
 
Event Description
The hospital reported that during a procedure, the patient passed away. There was no report or allegation of a system malfunction.
 
Manufacturer Narrative
Additional information was received that the customer stated the device did not cause the patient death. The device performed to specifications and did not cause or contribute to the death. Additional information was received that the customer stated the device did not cause the patient death. The device performed to specifications and did not cause or contribute to the death.
 
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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 Key9880904
MDR Text Key184951508
Report Number2112667-2020-00951
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172045
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,Followup
Report Date 05/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Model Number1009-9000-000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/04/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/17/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/25/2020 Patient Sequence Number: 1
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