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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
Model Number 1009-9012-000
Device Problem Unexpected Therapeutic Results (1631)
Patient Problems Death (1802); Brain Injury (2219)
Event Date 03/24/2019
Event Type  Death  
Manufacturer Narrative
Ge healthcare's investigation into the reported occurrence is ongoing. A follow-up report will be issued when the investigation has been completed. Patient weight information unavailable. Device evaluation anticipated, but not yet begun.
 
Event Description
The hospital reported an alleged failure of the system resulting in excess co2, leading to brain injury during procedure and eventual patient death.
 
Manufacturer Narrative
After the reported event, a ge healthcare service representative performed a checkout of the system but did not find any issue with the system. The system performed as expected and was returned to service. Also, ge healthcare engineering performed an investigation of the reported event. The customer reported that the system did not malfunction during the case, but that past co2 reading errors (described as "unorganized co2 wave form or false low reading") on the gas module led the team to fail to respond appropriately to the "line occluded" message on the gas module in a timely manner, leading to an anoxic brain injury. The aespire 7900 is separate from the gas module, but readings from the gas module are used to inform users of settings and setup changes that should be made on the aespire 7900. Review of complaint data indicates no malfunction of the aespire 7900 system that could cause or contribute to a patient's death. The root cause is undetermined.
 
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Brand NameAESPIRE 7900
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
MDR Report Key8582628
MDR Text Key144147284
Report Number2112667-2019-00184
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K050626
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 06/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1009-9012-000
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/04/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/06/2019 Patient Sequence Number: 1
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