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

Model Number	2414
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned sensor was evaluated.During evaluation, the sensor passed all visual and functional testing; however, the sensor was only able to obtain spo2 and pulse rate values, but not sphb and spmet values with an "spo2 only mode" error message.The ¿spo2 only mode" message is related to a defective detector component.To address this issue; 100% screening has been implemented in the manufacturing process.
Event or Problem Description
It was reported that "during a methemoglobin study, the sensor displayed 0.0 for spmet for the entire study.The subject's methemoglobin level was increased during the study.Both of the other control sensors read the increasing met level, as well as the blood co-oximeter analyzers.The sensor in question did display other parameters, including pr, spo2, and pi.The sensor was tested on another test port, as well as on a radical-7 device, while the subject's spmet level was still raised.The spmet read 0.0 on the test device and -- on the radical-7." no known impact or consequence to patient was reported.

• Brand Name: RAINBOW R1 25L
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6666020
• Report Number: 2031172-2017-00670
• Device Sequence Number: 45939
• Product Code: DQA
• UDI-Device Identifier: 10843997002322
• UDI-Public: 10843997002322
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,health
• Initial Reporter Occupation: Nurse
• 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: 2414
• Device Catalogue Number: 2414
• Device Lot Number: 17ACC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2017
• Initial Report FDA Received Date: 06/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30
• Patient Weight: 75