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

Model Number	4003
Medical Device Problem Codes	Incorrect Measurement (1383); Sensing Intermittently (1558)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been returned to the local facility but has not yet been received at the main office for evaluation.Once returned and investigated, a follow-up report will be submitted.(b)(6).
Event or Problem Description
The customer reported that the sensors provided inaccurate pr values and intermittent spo2 readings.No consequences or impact to patient were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: the returned device was evaluated.During evaluation the device passed all visual and functional testing.During simulation testing, the device passed manual and preset conditions and provided accurate measurements.The unit was found to visually and audibly alarm during alarm conditions.The unit was determined to be functioning as designed., other, other text: initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: bt12 6ba initial reporter phone # is entered as (b)(6) to meet the minimum allowable characters.Initial reporter phone # is: (b)(6).
Event or Problem Description
The customer reported that the sensors provided inaccurate pr values and intermittent spo2 readings.No consequences or impact to patient were reported.

• Brand Name: RD SET NEO
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 11324017
• Report Number: 3011353843-2021-00034
• Device Sequence Number: 14493905
• Product Code: DQA
• UDI-Device Identifier: 10843997009598
• UDI-Public: 10843997009598
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K042536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2021

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: 06/01/2023
• Device Model Number: 4003
• Device Catalogue Number: 4003
• Device Lot Number: E20FWV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 MO