MAUDE Adverse Event Report: MASIMO - 40 PARKER RAINBOW DCI SC 200; OXIMETER

Model Number	3418
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple attempts for product return and requests for additional information were made.The product has not been returned to masimo to allow an analysis to be performed.If new information is obtained or the product is returned, a follow up report will be submitted.,.
Event or Problem Description
The customer reported they are seeing a three point difference in the sphb reading from the pronto and a blood draw.No patient impact or consequences were reported.
Additional Manufacturer 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.Corrected data: lot #: updated from "a17e130" to "17gd2." device manufacture date updated from "07/06/2017" to "07/25/2017.".

• Brand Name: RAINBOW DCI SC 200
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 7298458
• Report Number: 2031172-2018-00123
• Device Sequence Number: 2314065
• Product Code: DQA
• UDI-Device Identifier: 00843997007269
• UDI-Public: 00843997007269
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K080238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• 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: 3418
• Device Catalogue Number: 3418
• Device Lot Number: 17GD2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 02/26/2018
• Supplement Report FDA Received Date: 04/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1