MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT MEXICO SA V-SAT VETERINARY SENSOR; OXIMETER

Model Number V-SAT

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Skin Erosion (2075)

Event Date 02/07/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during the operation with spo2 measurement, white burn-like erosion was produced at the sensor site.During the operation, the sensor stayed put at the same site on the tongue for 15 minutes without changing the site but the doctor swaddled the tongue with a water-wetted gauze before placing sensor.Also a sheet to block out light was covering the sensor site during the spo2 measurement.There was no reported patient outcome.

• Brand Name: V-SAT VETERINARY SENSOR
• 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: 10254030
• MDR Text Key: 198357124
• Report Number: 2936999-2020-00477
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K162014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V-SAT
• Device Catalogue Number: V-SAT
• Device Lot Number: 171490102H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2020
• Date Device Manufactured: 05/29/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1