MAUDE Adverse Event Report: MASIMO - 40 PARKER RAINBOW DCI; OXIMETER

Model Number	2696
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturing narrative: other, additional manufacturing narrative (if other): 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 there was poor readings.No known impact or consequence to patient.
Additional Manufacturer Narrative
Additional manufacturing narrative: the returned sensor was evaluated.During evaluation the sensor passed all visual and functional testing.The sensor was determined to be functioning as designed.

• Brand Name: RAINBOW DCI
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6268778
• Report Number: 2031172-2017-00090
• Device Sequence Number: 803296
• Product Code: DQA
• UDI-Device Identifier: 00843997004855
• UDI-Public: (01)00843997004855(11)160901(10)K16JP1
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K080238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,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: 2696
• Device Catalogue Number: 2696
• Device Lot Number: K16JP1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2017
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2017
• Supplement Report FDA Received Date: 04/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1