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

Model Number	2329
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/02/2017
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.(b)(6).
Event or Problem Description
The customer reported that these sensors were placed on a newborn baby, and were not able to accurately read the pulse even after several minutes, while another technology did.No consequences or impact to the patient were reported.
Additional Manufacturer Narrative
The returned sensor was evaluated.During evaluation, the sensor passed all visual and functional testing.The unit was determined to be functioning as designed.A complaint history review was performed for the involved product and lot.No confirmed issues related to the reported failure mode have been reported since the release of p/n 2329, lot k16kpx.Initial reporter zip code exceeded minimum allowable digits, zip code is as follows: (b)(6).Orrected data: (labeled for single use?) updated from "no" to "yes" (report source) updated from "health professional, foreign, user facility" to "foreign, company representatives, user facility".Model # updated from "2329-9" to "2329" exp.Date updated from "blank" to "10/01/2019".

• Brand Name: LNCS NEO
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6666021
• Report Number: 2031172-2017-00671
• Device Sequence Number: 1882100
• Product Code: DQA
• UDI-Device Identifier: 10843997000922
• UDI-Public: 10843997000922
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K101896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• 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 Expiration Date: 10/01/2019
• Device Model Number: 2329
• Device Catalogue Number: 2329
• Device Lot Number: K16KPX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 06/25/2017
• Supplement Report FDA Received Date: 08/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1