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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL CAPNOGRAPHY MONITOR CAPNOCHECK II; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
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SMITHS MEDICAL ASD, INC. SMITHS MEDICAL CAPNOGRAPHY MONITOR CAPNOCHECK II; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Back to Search Results
Catalog Number 8400D
Medical Device Problem Code Failure to Power Up (1476)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
One capnocheck monitor received for evaluation.Device was powered on as functional testing.As a result, it was noted the reported customer complaint has been confirmed.The customer's battery was charged over night, resulting in a functioning device.The cause of the reported problem was determined to be a dead battery.
 
Event or Problem Description
Information was received that a smiths medical capnography monitor capnocheck does not power on.It was reported device has only black lines.No adverse effects were reported.
 
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Brand Name
SMITHS MEDICAL CAPNOGRAPHY MONITOR CAPNOCHECK II
Common Device Name
ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key8927546
Report Number3012307300-2019-04036
Device Sequence Number242674
Product Code CCK
UDI-Device Identifier10610586036736
UDI-Public10610586036736
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K991086
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/23/2019
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
Operator of Device No Information
Device Catalogue Number8400D
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/26/2019
Initial Report FDA Received Date08/23/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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