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

Model Number	MAXNJ
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report where it was alleged that the unit provided a reading that was lower than the expected value and the problem was isolated to the reported sensor.The customer indicated that there was no patient harm.
Additional Manufacturer Narrative
One sample was received for analysis and the reported issue could not be confirmed.A visual and functional evaluation was performed and there was no defect found.It passed both oximeter and continuity tests successfully.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report where it was alleged that the unit provided a reading that was lower than the expected value and the problem was isolated to the reported sensor.The customer indicated that there was no patient harm.

• Brand Name: NELLCOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): NELLCOR PURITAN BENNETT MEXICO SA; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• MDR Report Key: 6802773
• Report Number: 1282497-2017-05282
• Device Sequence Number: 1267452
• Product Code: DQA
• UDI-Device Identifier: 20884522041710
• UDI-Public: 20884522041710
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K052186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2017

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 Expiration Date: 05/20/2019
• Device Model Number: MAXNJ
• Device Catalogue Number: MAXNJ
• Device Lot Number: 161410100H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Initial Date Received by Manufacturer: 07/26/2017
• Supplement Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 08/17/2017
• Supplement Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1