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

Model Number	2320
Medical Device Problem Codes	Device Alarm System (1012); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned sensor was evaluated.During inspection, the sensor passed software testing and visual analysis.The sensor failed continuity testing due to broken green and white conductors at the detector solder joint assembly.During testing, the sensor was able to generate audible and visual alarms, and an error message indicating "probe is off the patient." the reported issue was not confirmed.
Event or Problem Description
The customer reported the following issue: "if the probe goes bad (we have had a few), there is no alarm, the patient is then hooked up with no sats on the monitor." no consequences or impact to patient were reported.

• Brand Name: LNCS NEO-3
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6778934
• Report Number: 2031172-2017-00776
• Device Sequence Number: 19082556
• Product Code: DQA
• UDI-Device Identifier: 10843997000892
• UDI-Public: (01)10843997000892(17)200101(10)K17A1E
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,user f
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial

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: 2320
• Device Catalogue Number: 2320
• Device Lot Number: K17A1E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 08/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1