MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT MEXICO SA NELLCOR; OXIMETER

Model Number MAX-N-I

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Burn(s) (1757)

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during use, patient had burns occurrence in the sensor area specifically on one feet and sensor was changed to different feet due to the issue.Some coinciding with the light despite the use of protectors, and others in the cable support area.The user changed the sensor place every 8 hours.The degree of burns affected the superficial dermis.

• 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: clay chandler ; 5920 longbow drive; boulder, CO 80301 ; 3035306409
• MDR Report Key: 14523250
• MDR Text Key: 292820335
• Report Number: 1282497-2022-00041
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 20884522040379
• UDI-Public: 20884522040379
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K012891
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAX-N-I
• Device Catalogue Number: MAX-N-I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1