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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT MEXICO SA NELLCOR; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
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NELLCOR PURITAN BENNETT MEXICO SA NELLCOR; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Back to Search Results
Model Number EASYCAP6J
Device Problem Device Ingredient or Reagent Problem (2910)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/10/2022
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, the device's color did not change even it was used on the patient.The patient was firmly intubated when checked via x-ray.There was no patient harm.
 
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Brand Name
NELLCOR
Type of Device
ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Manufacturer (Section D)
NELLCOR PURITAN BENNETT MEXICO SA
boulevard insurgentes 19030
tijuana 22225
MX  22225
Manufacturer (Section G)
NELLCOR PURITAN BENNETT MEXICO SA
boulevard insurgentes 19030
tijuana 22225
MX   22225
Manufacturer Contact
clay chandler
5920 longbow drive
boulder, CO 80301
3035306409
MDR Report Key13793328
MDR Text Key292366361
Report Number2936999-2022-00230
Device Sequence Number1
Product Code CCK
UDI-Device Identifier10884521709829
UDI-Public10884521709829
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K894053
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 03/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEASYCAP6J
Device Catalogue NumberEASYCAP6J
Was Device Available for Evaluation? No
Date Manufacturer Received02/15/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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