MAUDE Adverse Event Report: MASIMO - 40 PARKER RAINBOW R1 25L; OXIMETER

Model Number	2414
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturing narrative: 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
Patient 1 of 3.The customer reported: "multiple sensor failures with r125l rainbow sensors losing sphb measurements during use.Error message reads ¿spo2 only".Sensors work as expected initially, then 1-2 hours after surgery begins lose all rainbow measurements (sphb and spmet) giving ¿spo2 only" message.Or environment during cardiothoracic surgery and cardiopulmonary bypass on infants around 3-10 kgs, with normal skin tones and moderate but adequate perfusion.Patients are under sterile drapes with no access to sensors during surgery".No consequences or impact to patient was reported.
Additional Manufacturer Narrative
Additional manufacuring narrative: other, additional manufacturing narrative (if other): two (2) sensors were returned and evaluated.During evaluation the sensors passed all visual and functional testing.The sensors were determined to be functioning as designed.

• Brand Name: RAINBOW R1 25L
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6875001
• Report Number: 2031172-2017-00887
• Device Sequence Number: 13781163
• Product Code: DQA
• UDI-Device Identifier: 10843997002322
• UDI-Public: 10843997002322
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K081659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• 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 Expiration Date: 03/01/2020
• Device Model Number: 2414
• Device Catalogue Number: 2414
• Device Lot Number: R17GXH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 08/23/2017
• Supplement Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 09/19/2017
• Supplement Report FDA Received Date: 11/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 3