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

Model Number POSEY

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Skin Irritation (2076)

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, the device had a skin integrity issue.The patient had scratches and marks on the foot.

• 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 Key: 9372713
• MDR Text Key: 168437400
• Report Number: 2936999-2019-00971
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10884521144897
• UDI-Public: 10884521144897
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K012891
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: POSEY
• Device Catalogue Number: POSEY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2019
• 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 Age: 3 MO