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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
Device Problems Human-Device Interface Problem (2949); Patient Device Interaction Problem (4001)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 05/24/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event 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
Type of Device
OXIMETER
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
avi kluger
5920 longbow drive
boulder, CO 80301
3035306582
MDR Report Key12000213
MDR Text Key256230968
Report Number1282497-2021-00031
Device Sequence Number1
Product Code DQA
UDI-Device Identifier30884521080557
UDI-Public30884521080557
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K904039
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 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
Device Operator Health Professional
Device Model NumberRS10
Device Catalogue NumberRS10
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/24/2021
Initial Date FDA Received06/15/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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