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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA INC AVANCE GAS-MACHINE, ANESTHESIA

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DATEX-OHMEDA INC AVANCE GAS-MACHINE, ANESTHESIA Back to Search Results
Model Number CS2
Device Problem Communication or Transmission Problem (2896)
Patient Problem Insufficient Information (4580)
Event Date 10/09/2020
Event Type  malfunction  
Event Description
Anesthesia machine not sending data to electronic privacy information center (epic).
 
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Brand NameAVANCE
Type of DeviceGAS-MACHINE, ANESTHESIA
Manufacturer (Section D)
DATEX-OHMEDA INC
3030 ohmeda drive
madison WI 53718
MDR Report Key10902522
MDR Text Key218219283
Report Number10902522
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 11/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCS2
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/24/2020
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer11/25/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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