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

Model Number MAXFAST

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Skin Irritation (2076)

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

The sample associated to this report is not expected to be returned for analysis.Information has been added to the database for trending purposes.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Customer reported that the sensor caused skin reactions on the patient.The patient was post open heart procedure.It was reported that the patient was on a ventilator for more than three days and that the use of the sensor was stopped as a result of the reported skin reaction.The skin was treated and no additional harm to the patient was reported.

Manufacturer Narrative

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

• Brand Name: NELLCOR
• Type of Device: OXIMETER
• Manufacturer (Section D): NELLCOR PURITAN BENNETT MEXICO SA; boulevard insurgentes 19030; tijuana
• Manufacturer (Section G): NELLCOR PURITAN BENNETT MEXICO SA; boulevard insurgentes 19030; tijuana
• Manufacturer Contact: sharon murphy ; 15 hampshire street; mansfield, MA 02048 ; 2034925267
• MDR Report Key: 6377194
• MDR Text Key: 69045809
• Report Number: 2936999-2017-05025
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2017

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: MAXFAST
• Device Catalogue Number: MAXFAST
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2017
• Initial Date FDA Received: 03/03/2017
• Supplement Dates Manufacturer Received: 02/02/2017
• Supplement Dates FDA Received: 09/06/2017
• 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