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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 Electrical /Electronic Property Problem (1198)
Patient Problem No Patient Involvement (2645)
Event Date 07/02/2018
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. Device evaluation anticipated, but not yet begun.
 
Event Description
The hospital reported an electrical failure of the unit. There was no report of patient involvement.
 
Manufacturer Narrative
Additional information was received that this was a malfunction of the internal battery. Preuse checkout verifies the battery function. When the unit switches to battery, it notifies the user. If the battery is depleted, ventilation of the patient can continue in manual mode. This was not a reportable malfunction.
 
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Brand NameCARESTATION 620
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
MDR Report Key7735263
MDR Text Key115567219
Report Number2112667-2018-01505
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 08/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/06/2018
Is This a Reprocessed and Reused Single-Use Device? No

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