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

Model Number	2329
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/09/2017
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
It was reported that the sensors had not working correctly in or & pacu over the last 30 days.The sensor would come with the patient from the or.It would work for a few seconds to two minutes and ¿flash out".Problem occurred with sensors from cardinal health pre-op packs as well as loose masimo sensor stock.No error message or audible alarm was mention.No known impact or consequence to patient.
Additional Manufacturer Narrative
Additional manufacuring 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
Unique identifier (udi) #, was updated from ni to (b)(4).

• Brand Name: LNCS NEO
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6370815
• Report Number: 2031172-2017-00288
• Device Sequence Number: 442827
• Product Code: DQA
• UDI-Device Identifier: 10843997000922
• UDI-Public: (01)10843997000922(17)191101(10)K16MYT
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K094046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• 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: 2329
• Device Catalogue Number: 2329
• Device Lot Number: K16MYT
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/20/2017
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/09/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/01/2017
• Supplement Report FDA Received Date: 03/23/2017; 05/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1