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U.S. Department of Health and Human Services

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

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DATEX-OHMEDA, INC. AISYS CS2; ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Battery Problem (2885)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/24/2020
Event Type  malfunction  
Manufacturer Narrative
Third party service stated that the battery was replaced the battery after the failure.Patient information could not be obtained 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.Third party service stated that the battery was replaced the battery after the failure.Patient information could not be obtained due to country privacy laws.
 
Event Description
The hospital reported a failure to switch to battery when the ac power was lost during use.There was no report of patient injury.
 
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Brand Name
AISYS CS2
Type of Device
ANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer Contact
john szalinski
MDR Report Key10437670
MDR Text Key203898655
Report Number2112667-2020-02297
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K132530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial
Report Date 08/21/2020
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 07/24/2020
Initial Date FDA Received08/21/2020
Date Device Manufactured11/14/2014
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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