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

Model Number	2505-2
Medical Device Problem Codes	Incorrect Measurement (1383); Low Readings (2460)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned sensor was evaluated.The sensor passed visual inspection with no damage observed.Further review found the sensor had failed continuity testing due to an open cable on the white conductor at the sensor end.The customer complaint was duplicated.When the sensor was connected to a masimo monitoring device, the device was able to generate a "sensor off patient" error message.(b)(6).
Event or Problem Description
The customer reported fifteen m-lncs y-i sensors, some occur sensor off, some occur replace sensor, some spo2 and bpm are very low, all the issues are intermittent, the customer couldn't match the issue with the corresponding sensor.No patient incident or consequences were reported.

• Brand Name: M-LNCS YI
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6908238
• Report Number: 2031172-2017-00923
• Device Sequence Number: 18863104
• Product Code: DQA
• UDI-Device Identifier: 00843997003254
• UDI-Public: 00843997003254
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K041815
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• 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: Other
• Device Expiration Date: 09/01/2019
• Device Model Number: 2505-2
• Device Catalogue Number: 2505
• Device Lot Number: K16JXE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2017
• Initial Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1