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

Model Number MAXN

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Skin Irritation (2076)

Event Date 01/16/2019

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 sensor irritated the patient's skin at the bottom of the left foot.The customer reported that it left a dark marking on patient, which persisted about one to two weeks and skin was red.

• 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: 8342773
• MDR Text Key: 136239950
• Report Number: 9610849-2019-00004
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 20884522041727
• UDI-Public: 20884522041727
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012891
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: MAXN
• Device Catalogue Number: MAXN
• Device Lot Number: 183130152H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2019
• Date Device Manufactured: 11/16/2018
• 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
• Patient Age: 7 MO
• Patient Weight: 5