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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESPIRE VIEW ANESTHESIA GAS MACHINE

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DATEX-OHMEDA, INC. AESPIRE VIEW ANESTHESIA GAS MACHINE Back to Search Results
Device Problems Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 07/24/2018
Event Type  malfunction  
Manufacturer Narrative
No report of patient involvement. (b)(4). Ge healthcare's investigation into the reported occurrence is ongoing. A follow-up report will be issued when the investigation has been completed. Device evaluation anticipated, but not yet begun.
 
Event Description
The hospital reported the unit had an error that results in a loss of mechanical ventilation. There was no report of patient involvement.
 
Manufacturer Narrative
A ge healthcare service representative performed a checkout of the equipment and confirmed the reported complaint. The flow sensor and sensor interface board were replaced. The unit was returned to service.
 
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Brand NameAESPIRE VIEW
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
MDR Report Key7809003
MDR Text Key118395009
Report Number2112667-2018-01663
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K092864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 08/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/24/2018
Is This a Reprocessed and Reused Single-Use Device? No

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