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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL CAPNOCHECK SLEEP OXIMETER ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

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NULL CAPNOCHECK SLEEP OXIMETER ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Back to Search Results
Catalog Number 9004051-00
Device Problem Unable to Obtain Readings (1516)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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Brand NameCAPNOCHECK SLEEP OXIMETER
Type of DeviceANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Manufacturer (Section G)
NULL
MDR Report Key15328896
Report Number3012307300-2022-17070
Device Sequence Number1
Product Code CCK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K970209
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/31/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9004051-00
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/17/2020
Was the Report Sent to FDA? No
Date Manufacturer Received04/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/03/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

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