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

Model Number	4029-9
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts have been made to obtain the product.The product has not been returned to masimo to allow an analysis to be performed.If the product is returned for evaluation or new information is obtained, a follow up report will be submitted.
Event or Problem Description
The customer reported inaccurate measurements.No patient impact or consequences were reported.
Event or Problem Description
The customer reported inaccurate measurements.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: the returned sensor was evaluated.Visual inspection upon receiving revealed no external damage or defects.The sensor passed continuity tests.No electrical short or open connection was detected, and no intermittent electrical short or open connection was detected when the sensor was manipulated.The sensor was able to obtain sphb, spmet, spo2, and pulse rate values.During comparison testing, the sensor provided values that were within specifications.The sensor was determined to be functioning as designed.

• 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: 8795184
• Report Number: 3011353843-2019-00001
• Device Sequence Number: 2638933
• Product Code: DQA
• UDI-Device Identifier: 10843997010938
• UDI-Public: 10843997010938
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K042536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2019

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: 05/01/2022
• Device Model Number: 4029-9
• Device Catalogue Number: 4029
• Device Lot Number: 19ERJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 69