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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
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/15/2020
Event Type  malfunction  
Manufacturer Narrative
No report of patient involvement. Ge healthcare (gehc) became aware of an isolated customer contact platform which did not correctly categorize certain (b)(6)-based customer calls. Gehcs investigation into the issue identified that some (b)(6)-based customer calls were not considered for complaint evaluation if the customer did not retain a service or warranty contract, and the customer also did not accept a quote for service from gehc. As part of gehcs investigation, this specific call record was determined to be a reportable event and is being reported outside of the 30-day reporting timeline. This process non-conformance is being addressed via gehcs capa system to: report any appropriate records/events which have not been reported as a result of this issue. Prevent future occurrence.
 
Event Description
The hospital reported unit "crash". No further details available. No patient involvement reported.
 
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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 (Section G)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer Contact
john szalinski
MDR Report Key12327833
MDR Text Key268150818
Report Number2112667-2021-01902
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K172045
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 08/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received10/15/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/25/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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