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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. CARESTATION 620; ANESTHESIA GAS MACHINE
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DATEX-OHMEDA, INC. CARESTATION 620; ANESTHESIA GAS MACHINE Back to Search Results
Model Number 1012-9620-000
Device Problems Gas/Air Leak (2946); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Date 02/09/2021
Event Type  malfunction  
Manufacturer Narrative
No report of patient involvement.Unique identifier: (b)(4).A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The advanced breathing system and check valves were cleaned and dried to resolve the reported issue.
 
Event Description
The hospital reported a reverse flow error preventing mechanical ventilation.There was no report of patient involvement.
 
Manufacturer Narrative
Additional information was received the the leak was less than 4.5lpm.A leak condition will be noted in the preop check of the equipment, as contained in the user manual.The leak may be able to be compensated for or made up with fresh gas flow.Mechanical ventilation is not impacted by the reported issue.H3 other text : additional information was received the the leak was less than 4.5lpm.A leak condition will be noted in the preop check of the equipment, as contained in the user manual.The leak may be able to be compensated for or made up with fresh gas flow.Mechanical ventilation is not impacted by the reported issue.
 
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Brand Name
CARESTATION 620
Type of Device
ANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
MDR Report Key11454182
MDR Text Key240980465
Report Number2112667-2021-00650
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K151570
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 03/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1012-9620-000
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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