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

Model Number V-SAT

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Burn(s) (1757)

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 gonadectomy procedure with spo2 measurement, the sensor caused a low temperature burn on an animal tongue.

• 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: 9439052
• MDR Text Key: 169908369
• Report Number: 2936999-2019-01004
• 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: 12/09/2019

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: V-SAT
• Device Catalogue Number: V-SAT
• Device Lot Number: 122770084X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/21/2019
• Initial Date FDA Received: 12/09/2019
• 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