MAUDE Adverse Event Report: MASIMO - 40 PARKER RD RAINBOW SET-2 NEO; OXIMETER

Model Number	4029-1
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer 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
The customer reported that after 10 minutes of monitoring it stopped measuring.After a while it started measuring again with no problem for measurement.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: the returned sensor was evaluated.External visual inspection showed no damage.The sensor failed continuity testing due to an intermittent open in the emitter assembly.When connected to a monitor the sensor was able to obtain readings for approximately 8 minutes before function stopped and a "replace sensor" error was displayed on the monitor.The reported issue was confirmed.
Event or Problem Description
The customer reported that after 10 minutes of monitoring it stopped measuring.After a while it started measuring again with no problem for measurement.No patient impact or consequences were reported.

• Brand Name: RD RAINBOW SET-2 NEO
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 8689811
• Report Number: 2031172-2019-00289
• Device Sequence Number: 11518250
• Product Code: DQA
• UDI-Device Identifier: 10843997010938
• UDI-Public: 10843997010938
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2019

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: 07/01/2021
• Device Model Number: 4029-1
• Device Catalogue Number: 4029
• Device Lot Number: 18GHR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 07/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1