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

Model Number	2653
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned sensor was evaluated.During evaluation the unit failed continuity testing due to an open in the cable on the white conductor at the bend relief area of the db9 connector.Open in the cable was most likely due to mechanical stress during removal of the sensor from the cable based upon the appearance and location of the open.The sensor functioned intermittently.The sensor was able to obtain spo2 and pulse rate values when the connection was held in normal operation.When the sensor was manipulated to "open" (non functional), the device alarmed and an error message displayed on the test monitor.
Event or Problem Description
The customer reported that the "sensor is presenting an intermittent reading." no known impact or consequence to patient were reported.

• Brand Name: LNCS DB-I
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 8384324
• Report Number: 2031172-2019-00101
• Device Sequence Number: 19278972
• Product Code: DQA
• UDI-Device Identifier: 00843997003094
• UDI-Public: 00843997003094
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K051212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/07/2019

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: 2653
• Device Catalogue Number: 2653
• Device Lot Number: K16MYF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 03/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1