MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RD RAINBOW SET-2 NEO; OXIMETER

Model Number	4029
Medical Device Problem Codes	Sensing Intermittently (1558); High Readings (2459)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturing 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.Other text : device not returned.
Event or Problem Description
The customer reported high sphb values and the device enters spo2 mode only and the sphb drops off.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacuring narrative: other, other text: the returned sensor was evaluated.During evaluation the sensor passed all visual, continuity, and functional testing.No short or open connection was detected, and no intermittent short or open connection was detected when the sensor was manipulated.The returned sensor was placed on a finger and was able to obtain sphb, spmet, spo2, and pulse rate values throughout the entire 15 minutes of testing.No ¿spo2 only mode" message or ¿drops off" were observed.The sensor readings were compared to a lab sensor readings and the values were found to be within the sphb accuracy of ± 1 g/dl.The sensor passed the comparison test and was found to be functioning as designed.
Event or Problem Description
The customer reported high sphb values and the device enters spo2 mode only and the sphb drops off.No patient impact or consequences were reported.

• Brand Name: RD RAINBOW SET-2 NEO
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 9653770
• Report Number: 3011353843-2020-00013
• Device Sequence Number: 14164161
• Product Code: DQA
• UDI-Device Identifier: 10843997010938
• UDI-Public: 10843997010938
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2020

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: 08/01/2022
• Device Model Number: 4029
• Device Catalogue Number: 4029
• Device Lot Number: 19HYR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RADICAL-7; RD RAINBOW PATIENT CABLE; ROOT
• Patient Age: 4 MO