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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
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem No Patient Involvement (2645)
Event Date 10/21/2019
Event Type  malfunction  
Manufacturer Narrative
Ge healthcare's 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).Device evaluation anticipated, but not yet begun.
 
Event Description
The hospital reported an over delivery of pressure in the patient circuit.There was no report of patient involvement.
 
Manufacturer Narrative
This event was reviewed by product engineering.The message circuit pressure too high is a failure message in ventilator checkout only when the latch valve fails in the open position.The user will still be able to start mechanical and manual ventilation.No high pressure will be delivered during a case.This was not a reportable malfunction.
 
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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 Key9340499
MDR Text Key214800288
Report Number2112667-2019-02272
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 foreign,health professional,u
Type of Report Initial,Followup
Report Date 11/20/2019
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 10/21/2019
Initial Date FDA Received11/19/2019
Supplement Dates Manufacturer Received11/18/2019
Supplement Dates FDA Received11/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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