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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SALTER LABS ETCO2 DIVIDED SAMPLING CANNULA

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SALTER LABS ETCO2 DIVIDED SAMPLING CANNULA Back to Search Results
Model Number 4707F
Event Date 10/23/2012
Event Type  Other  
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Brand NameETCO2 DIVIDED SAMPLING CANNULA
Type of DeviceSAMPLING CANNULA
Manufacturer (Section D)
SALTER LABS
arvin CA
Manufacturer Contact
colleen moyna, manager
100 west sycamore rd.
arvin , CA 93203
6618546862
MDR Report Key2913039
Report Number2921601-2013-00001
Device Sequence Number1
Product CodeCCK
Report Source Manufacturer
Source Type Other
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 01/08/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/08/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number4707F
Device Catalogue Number4707F
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received12/18/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 01/08/2013 Patient Sequence Number: 1
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