MAUDE Adverse Event Report: MASIMO - 40 PARKER LNC-10-GE; OXIMETER

Model Number	2016
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple attempts for product return and requests for additional information were made.The product has not been returned to masimo to allow an analysis to be performed.If new information is obtained or the product is returned, a follow up report will be submitted.
Event or Problem Description
The customer reported theyhave experienced discrepancies in abgs while using ge b650 monitors with masimo set and stryker reprocessed.For the past week, customer used masimo neo sensors (not reprocessed) with similar discrepancies.Ge monitor with set usually reads higher than the blood gas spo2.Customer submitted all samples, those that correlate and those that did not because they want to understand the problem.Staff does not know if they can trust the monitor and their physicians do not trust the saturation on the monitor.This is an ongoing issue and the customer is concerned with patient safety and liability for unreliable spo2 readings.No patient impact or consequences were reported.
Additional Manufacturer Narrative
The returned cable was evaluated.During evaluation the cable passed all visual and functional testing.The cable was determined to be functioning as designed.

• Brand Name: LNC-10-GE
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6840816
• Report Number: 2031172-2017-00862
• Device Sequence Number: 661991
• Product Code: DQA
• UDI-Device Identifier: 00843997000550
• UDI-Public: 00843997000550
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K101896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup

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: 2016
• Device Catalogue Number: 2016
• Device Lot Number: 13GHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 08/10/2017
• Supplement Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 09/04/2017
• Supplement Report FDA Received Date: 10/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1