MAUDE Adverse Event Report: MASIMO - 40 PARKER LNCS NEO-3; OXIMETER

Model Number	2320
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts have been made to obtain the product.The product has not been returned to masimo to allow an analysis to be performed.If the product is returned for evaluation or new information is obtained, a follow up report will be submitted.
Event or Problem Description
The customer reported the patient was reading low sao2, patient did not appear in distress but was just trached and on sedation.Oxygen saturation reading 84% with perfusion of 0.35-.065.A forehead probe was tried with change in reading to 90%, but no significant change in perfusion the finger probe changed to alternate location, again with no significant change in perfusion or reading.The patient was given 100% fio2 to see if saturation would increase, it did not.Non-disposable finger probe tried, perfusion only increased to 0.7 but now with sat of 95% the ear clip did not read at all, the range of sats obtained from the pt were 84-95%, all with a perfect pleth and all with a perf in the 0.5-0.65 range.No patient impact or consequences were reported.
Event or Problem Description
The customer reported the patient was reading low sao2, patient did not appear in distress but was just trached and on sedation.Oxygen saturation reading 84% with perfusion of 0.35-.065.A forehead probe was tried with change in reading to 90%, but no significant change in perfusion the finger probe changed to alternate location, again with no significant change in perfusion or reading.The patient was given 100% fio2 to see if saturation would increase, it did not.Non-disposable finger probe tried, perfusion only increased to 0.7 but now with sat of 95% the ear clip did not read at all, the range of sats obtained from the pt were 84-95%, all with a perfect pleth and all with a perf in the 0.5-0.65 range.No patient impact or consequences were reported.
Additional Manufacturer Narrative
The returned sensor was evaluated.During evaluation the sensor passed all visual and functional testing.The sensor was determined to be functioning as designed.

• Brand Name: LNCS NEO-3
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 7657491
• Report Number: 2031172-2018-00366
• Device Sequence Number: 122273
• Product Code: DQA
• UDI-Device Identifier: 10843997000892
• UDI-Public: 10843997000892
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2018

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: 02/01/2021
• Device Model Number: 2320
• Device Catalogue Number: 2320
• Device Lot Number: 18BBT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LNCS TFA-1 SENSOR; LNCS TFA-1 SENSOR