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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 Decrease in Suction (1146)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/24/2021
Event Type  malfunction  
Manufacturer Narrative
Ge healthcare investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.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 malfunction causing a loss of suction.There was no report of patient involvement.
 
Manufacturer Narrative
A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The tubing was noted to be twisted and was subsequently replaced to resolve the issue.
 
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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
MDR Report Key12040340
MDR Text Key260961545
Report Number2112667-2021-01567
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,Followup
Report Date 06/29/2021
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? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/24/2021
Initial Date FDA Received06/22/2021
Supplement Dates Manufacturer Received06/22/2021
Supplement Dates FDA Received06/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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