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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AMINGO; ANESTHESIA GAS MACHINE

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DATEX-OHMEDA, INC. AMINGO; ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Loss of Power (1475)
Patient Problem No Patient Involvement (2645)
Event Date 12/01/2016
Event Type  malfunction  
Manufacturer Narrative
The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.The amingo is not sold in the usa and has no 510(k).However, the device is similar to the avance, 510(k) k032803.Ge healthcare¿s investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Device evaluation anticipated, but not yet begun.
 
Event Description
The hospital reported that the unit shut down during the preoperative checkout.There was no report of patient involvement.
 
Manufacturer Narrative
This event was already reported on mdr 2112667-2016-02570.This report is a duplicate and should be disregarded.
 
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Brand Name
AMINGO
Type of Device
ANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda drive
madison WI
Manufacturer Contact
joseph seliga
3000 n grandview blvd.
waukesha, WI 
MDR Report Key6213490
MDR Text Key63804401
Report Number2112667-2016-02548
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
NA
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 12/29/2016
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 12/01/2016
Initial Date FDA Received12/29/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/1970
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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