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

Model Number 904-N

Device Problem Contamination /Decontamination Problem (2895)

Patient Problems Pain (1994); 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, there was a skin rash on the foot where the saturation was placed.It was reported that the position of the sensor was changed.It was reported that there was pain at palpation and persistence of the altered stated of skin, which necessary to apply scar cream.

• 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: 8354221
• MDR Text Key: 136640634
• Report Number: 1282497-2019-00007
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 20884521084107
• UDI-Public: 20884521084107
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K993637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 904-N
• Device Catalogue Number: 904-N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2019
• 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 Outcome(s): Other
• Patient Age: 2 MO
• Patient Weight: 3