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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT MEXICO SA NELLCOR; OXIMETER
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NELLCOR PURITAN BENNETT MEXICO SA NELLCOR; OXIMETER Back to Search Results
Model Number MAXA
Medical Device Problem Code Incorrect Measurement (1383)
Health Effect - Clinical Code Low Oxygen Saturation (2477)
Date of Event 11/30/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, the sensor had a failure.It was indicated that the o2 sensor was reporting normal o2 sat on monitor, but (abg) arterial blood gas showed hypoxemia.The o2 sensor was changed then the o2 sat reflected abg result.It was indicated that they compared readings for sensor with arterial blood gas and then swapped sensor to isolate to the sensor being the problem.The patient experienced hypoxemia.
 
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Brand Name
NELLCOR
Common Device Name
OXIMETER
Manufacturer (Section D)
NELLCOR PURITAN BENNETT MEXICO SA
boulevard insurgentes 19030
tijuana 22225
MX  22225
MDR Report Key11064412
Report Number1282497-2020-00056
Device Sequence Number2560313
Product Code DQA
UDI-Device Identifier20884522040089
UDI-Public20884522040089
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K012891
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 12/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberMAXA
Device Catalogue NumberMAXA
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/30/2020
Initial Report FDA Received Date12/23/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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