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

Model Number	D-YS
Medical Device Problem Codes	Device Alarm System (1012); False Reading From Device Non-Compliance (1228)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/16/2018
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 had an erratic spo2 reading.It was reported that when the sensor was disconnected from the patient, there is no alarm.Customer reported that there was no patient injury.

• 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: 7468176
• Report Number: 1282497-2018-00317
• Device Sequence Number: 172597
• Product Code: DQA
• UDI-Device Identifier: 20884522042540
• UDI-Public: 20884522042540
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K012891
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/27/2018

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: 12/31/2021
• Device Model Number: D-YS
• Device Catalogue Number: D-YS
• Device Lot Number: 162810030H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1