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

Model Number	2514-9
Medical Device Problem Codes	Incorrect Measurement (1383); Device Stops Intermittently (1599)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been returned to masimo for evaluation.When the investigation is complete, a follow up report will be submitted.
Event or Problem Description
The customer reported false reading, dropped signals, or weak readings and that the photo detector is out of the window on many of the sensors.No patient impact or consequences reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, additional manufacturing narrative (if other): the returned sensor was evaluated.During evaluation the sensor passed all visual and functional testing.The sensor was determined to be functioning as designed.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: M-LNCS NEO
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6081048
• Report Number: 2031172-2016-01229
• Device Sequence Number: 10898786
• Product Code: DQA
• UDI-Device Identifier: 10843997002568
• UDI-Public: (01)10843997002568(17)190701(10)16G3M
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup,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: 2514-9
• Device Catalogue Number: 2514
• Device Lot Number: 16G3M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2016
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/19/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/07/2016
• Supplement Report FDA Received Date: 11/29/2016; 01/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1