MAUDE Adverse Event Report: MASIMO - 40 PARKER LNCS NEO; OXIMETER

Model Number	2329
Medical Device Problem Codes	Incorrect Measurement (1383); Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The five returned sensors were evaluated.During evaluation the sensors passed all visual and functional testing.During simulation testing, the sensors were found to provide accurate measurements.No performance issues were identified.The reported issues were unable to be confirmed.
Event or Problem Description
The customer reported sensors were found to be faulty on five occasions within the same department and time frame.No consequences or impact to patient were reported.The maude database description of the issue (mw5081615) reads: "five different pts that had either no sao2 reading or wrong sao2 readings with the pulse oximeter probes by masimo, part #2329.".

• Brand Name: LNCS NEO
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 8166562
• Report Number: 2031172-2018-00577
• Device Sequence Number: 13928955
• Product Code: DQA
• UDI-Device Identifier: 10843997000922
• UDI-Public: 10843997000922
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/07/2018

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: 09/01/2021
• Device Model Number: 2329
• Device Catalogue Number: 2329
• Device Lot Number: E18JKE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1