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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 Problems Crack (1135); Mechanical Problem (1384)
Patient Problem No Patient Involvement (2645)
Event Date 06/30/2020
Event Type  Malfunction  
Manufacturer Narrative

A ge healthcare service representative performed a checkout of the system and confirmed the reported issue. The bag to vent switch was replaced to resolve the reported issue. No report of patient involvement. The initial reporter is located outside the u. S. , and therefore this information is not provided due to country privacy laws. Unique identifier: (b)(4).

 
Event Description

The hospital reported a cracked bag to vent switch preventing the selection of mechanical ventilation. There was no report of patient involvement.

 
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Brand NameAISYS CS2
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer Contact
john szalinski
3000 n grandview blvd.
waukesha, WI 
MDR Report Key10326076
MDR Text Key201897718
Report Number2112667-2020-02101
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
PMA/PMN NumberK132530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Type of Report Initial
Report Date 07/27/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/27/2020
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
Event Location No Information
Date Manufacturer Received06/30/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/23/2020
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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