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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 RS10
Medical Device Problem Codes Human-Device Interface Problem (2949); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code Unspecified Tissue Injury (4559)
Date of Event 05/24/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, it was noted that the site did not check the sensor every amount of hours to confirm that the device was not leaving pressure on the patient.In addition they did not move the sensor as well and noted that instead of a burn it was considered a pressure wound since there was no heat noted to came from the sensor.The patient experienced pressure injury.
 
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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 Key12000213
Report Number1282497-2021-00031
Device Sequence Number19909849
Product Code DQA
UDI-Device Identifier30884521080557
UDI-Public30884521080557
Combination Product (Y/N)N
Initial Reporter StateNE
Initial Reporter CountryUS
PMA/510(K) Number
K904039
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 06/15/2021
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 Health Professional
Device Model NumberRS10
Device Catalogue NumberRS10
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/24/2021
Initial Report FDA Received Date06/15/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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