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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPACELABS HEALTHCARE SPACELABS ANESTHESIA MACHINE

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SPACELABS HEALTHCARE SPACELABS ANESTHESIA MACHINE Back to Search Results
Model Number ARKON 99999
Device Problem Unable to Obtain Readings (1516)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/11/2017
Event Type  malfunction  
Event Description
During a surgical procedure, the arkon anesthesia machine display unit was unable to read / display the co2 values. A portable rgm was brought into the room to complete the case with. After the case, the machine was removed from service until the gas bench was replaced / recalibrated / tested / cleared by biomed.
 
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Brand NameSPACELABS
Type of DeviceANESTHESIA MACHINE
Manufacturer (Section D)
SPACELABS HEALTHCARE
MDR Report Key7120681
MDR Text Key95072164
Report NumberMW5073992
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 Received12/14/2017
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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