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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 Material Integrity Problem (2978)
Patient Problem No Patient Involvement (2645)
Event Date 11/15/2019
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).
 
Event Description
The hospital reported that monitor ventilator system was damaged preventing it from being latched to the base.There was no report of patient involvement.
 
Manufacturer Narrative
A proposal for diagnoses and repair was issued to the customer but not accepted at this time.No further information is available regarding the resolution of the reported issue.A proposal for diagnoses and repair was issued to the customer but not accepted at this time.No further information is available regarding the resolution of 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 Key9466551
MDR Text Key207342464
Report Number2112667-2019-02576
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 01/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2019
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
Date Manufacturer Received12/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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