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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AVANCE CS2; ANESTHESIA GAS MACHINE

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DATEX-OHMEDA, INC. AVANCE CS2; ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Loss of Power (1475)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/17/2015
Event Type  malfunction  
Manufacturer Narrative
A ge healthcare service representative performed a checkout of the equipment and confirmed the reported complaint.The batteries were replaced.Patient information could not be provided due to country privacy laws.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.
 
Event Description
The hospital reported that, during a case, the machine shut down.There was no reported patient injury.
 
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Brand Name
AVANCE CS2
Type of Device
ANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda drive
madison WI 53718
Manufacturer (Section G)
DATEX-OHMEDA, INC.
3030 ohmeda drive
madison WI 53718
Manufacturer Contact
brad wheeler
3000 n. grandview blvd., w450
waukesha, WI 53188
MDR Report Key5644400
MDR Text Key44849162
Report Number2112667-2016-00888
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K123125
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial
Report Date 05/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/13/2016
Initial Date FDA Received05/10/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/21/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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