MAUDE Adverse Event Report: COVIDIEN LP NELLCOR; OXIMETER, REPROCESSED

Model Number	MAXNR
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/04/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Patient needed a new oximeter probe.A new probe was placed and attached to the recording cable.Once attached the monitor read that the probe had a faulty sensor.This probe was removed and another new one was applied and again it read that the probe had a faulty sensor.This occurred again 10 days later with another patient.Uncertain of lot number but recorded the number of the same device that was next in the patient cart.May not be the correct lot number.

• Brand Name: NELLCOR
• Common Device Name: OXIMETER, REPROCESSED
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7218476
• Report Number: 7218476
• Device Sequence Number: 949341
• Product Code: DQA
• UDI-Device Identifier: 10884522042048
• UDI-Public: (01)10884522042048
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/16/2018
• Report Date (Section F): 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 07/31/2020
• Device Model Number: MAXNR
• Device Catalogue Number: MAXNR
• Device Lot Number: 172370093
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/16/2018