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

Model Number	V-SAT
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	03/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the device caused an ulcer tongue laceration to an animal.

• Brand Name: V-SAT VETERINARY SENSOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): NELLCOR PURITAN BENNETT MEXICO SA; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• MDR Report Key: 8503663
• Report Number: 9610849-2019-00011
• Device Sequence Number: 16522992
• Product Code: DQA
• UDI-Device Identifier: 10884522042468
• UDI-Public: 10884522042468
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K162014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2019

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
• Operator of Device: Health Professional
• Device Model Number: V-SAT
• Device Catalogue Number: V-SAT
• Device Lot Number: 180260229H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1