MAUDE Adverse Event Report: MASIMO - 40 PARKER RD SET DCI-P; OXIMETER

Model Number	4051-9
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned sensor was evaluated.During evaluation the sensor failed continuity tests using the cirris tester.Broken traces at the rd15 connector was observed causing multiple open connections.When tested with known good lab equipment a ¿sensor malf" error message displayed.
Event or Problem Description
It was reported that there were low spo2 readings.No known impact or consequence to patient.

• Brand Name: RD SET DCI-P
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6473844
• Report Number: 2031172-2017-00443
• Device Sequence Number: 13593559
• Product Code: DQA
• UDI-Device Identifier: 00843997009850
• UDI-Public: (01)00843997009850(11)161001(10)16KJA
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K051212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• 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: 4051-9
• Device Catalogue Number: 4051
• Device Lot Number: 16KJA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2017
• Initial Report FDA Received Date: 04/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1