MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT MEXICO SA VITAL VUE; ILLUMINATOR, FIBEROPTIC, SURGICAL FIELD

Model Number	8886828401
Medical Device Problem Codes	Break (1069); Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Information (3190)
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 membrane cracked, and there is a possible contamination.

• Brand Name: VITAL VUE
• Common Device Name: ILLUMINATOR, FIBEROPTIC, SURGICAL FIELD
• Manufacturer (Section D): NELLCOR PURITAN BENNETT MEXICO SA; boulevard insurgentes 1903; tijuana 22225 ; MX 22225
• MDR Report Key: 8522570
• Report Number: 9610849-2019-00012
• Device Sequence Number: 2798275
• Product Code: HBI
• UDI-Device Identifier: 10884521042445
• UDI-Public: 10884521042445
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K883201
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 04/17/2019

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: 8886828401
• Device Catalogue Number: 8886828401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 04/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1