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

Model Number	1861-9
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturing 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.
Event or Problem Description
The customer reported inaccurate spo2 readings.No consequences or impact to patient was reported.
Additional Manufacturer Narrative
The sensor was evaluated.During evaluation the sensor passed all visual and functional testing.The sensor was determined to be functioning as designed.Initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6).
Event or Problem Description
The customer reported inaccurate spo2 readings.No consequences or impact to patient was reported.

• Brand Name: LNCS INF-L
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 7729912
• Report Number: 2031172-2018-00406
• Device Sequence Number: 2541452
• Product Code: DQA
• UDI-Device Identifier: 10843997000304
• UDI-Public: 10843997000304
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K101896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2018

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: Lay User/Patient
• Device Expiration Date: 06/01/2020
• Device Model Number: 1861-9
• Device Catalogue Number: 1861
• Device Lot Number: 17FUH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 07/29/2018
• Supplement Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1