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

Model Number UNSPECIFIED OXIMAX SENSOR

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Event Description

According to the reporter, during use, the patient had a burn on the base of her finger from the sensor.

Manufacturer Narrative

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

• Brand Name: UNSPECIFIED OXIMAX SENSOR
• 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: 14205685
• MDR Text Key: 290071658
• Report Number: 2936999-2022-00340
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/26/2022

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 Number: UNSPECIFIED OXIMAX SENSOR
• Device Catalogue Number: UNSPECIFIED OXIMAX SENSOR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/26/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female