MAUDE Adverse Event Report: NELLCOR PURITA BENNET MEXICO SA NELLCOR; OXIMETER

Model Number MAXP

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, the device was causing burns in relation to the sensor.

• Brand Name: NELLCOR
• Type of Device: OXIMETER
• Manufacturer (Section D): NELLCOR PURITA BENNET MEXICO SA; boulevard insurgentes 19030; de cv; tijuana
• Manufacturer (Section G): NELLCOR PURITA BENNET MEXICO SA; boulevard insurgentes 19030; de cv; tijuana
• Manufacturer Contact: sharon murphy ; 15 hampshire street; mansfield, MA 02048 ; 2034925267
• MDR Report Key: 7197051
• MDR Text Key: 97430023
• Report Number: 1282497-2018-00040
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAXP
• Device Catalogue Number: MAXP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2017
• 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
• Patient Outcome(s): Other