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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS ANESTHESIA MACHINE ARKON

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SPACELABS HEALTHCARE INC. SPACELABS ANESTHESIA MACHINE ARKON Back to Search Results
Model Number ARKON 99999
Device Problems Loss of Power (1475); Computer Operating System Problem (2898)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/10/2017
Event Type  malfunction  
Event Description
During a surgical procedure, the arkon anesthesia machine's ventilator shut down and the machine unexpectedly entered a "failed state" mode. The anesthesia provider manually ventilated the pt as the machine was rebooted. After rebooting, the anesthesia machine returned to normal full operation with no resulting pt harm.
 
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Brand NameSPACELABS
Type of DeviceANESTHESIA MACHINE ARKON
Manufacturer (Section D)
SPACELABS HEALTHCARE INC.
MDR Report Key7124320
MDR Text Key95230294
Report NumberMW5074070
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/12/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberARKON 99999
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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