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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 Display or Visual Feedback Problem (1184)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/05/2022
Event Type  malfunction  
Manufacturer Narrative
A ge healthcare service representative performed a checkout of the system but did not confirm the reported issue. The carrier com express board was replaced preventatively despite not being able to reproduce the issue. No report of patient involvement. Unique identifier: (b)(4). The initial reporter is located outside the u. S. , and therefore this information is not provided due to country privacy laws. Legal manufacturer: (b)(4).
 
Event Description
The customer reported a malfunction resulting in the loss of display. There was no report of patient involvement.
 
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Brand NameCARESTATION 620
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer (Section G)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer Contact
anthony amenson
3030 ohmeda dr
madison, WI 53718
MDR Report Key15146571
MDR Text Key304539454
Report Number2112667-2022-02583
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K151570
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 08/02/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/05/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/08/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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