MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RAD-67 SPOT CHECK PULSE CO-OXIMETER

Model Number	25870
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/06/2020
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 the device was reading lower hemoglobin levels on patients than the results of blood gas analyzers.No patient impact or consequences were reported.
Event or Problem Description
The customer reported the device was reading lower hemoglobin levels on patients than the results of blood gas analyzers.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacuring 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: ne9 6sx.
Event or Problem Description
The customer reported the device was reading lower hemoglobin levels on patients than the results of blood gas analyzers.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: per masimo procedure smp-1333c sphb accuracy testing requires a minimum of thirteen (13) human subjects currently completing this testing is not possible due to the covid-19 pandemic.When it becomes safe to complete this testing an additional follow up with the results of the testing will be submitted.Initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6).H3 other text: testing cannot be completed at this time.

• Brand Name: RAD-67 SPOT CHECK PULSE CO-OXIMETER
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 10341662
• Report Number: 3011353843-2020-00120
• Device Sequence Number: 3065375
• Product Code: DQA
• UDI-Device Identifier: 00843997012812
• UDI-Public: 00843997012812
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K040214
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/06/2020

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 Model Number: 25870
• Device Catalogue Number: 9794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 02/03/2021; 03/04/2021
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 02/22/2021; 03/26/2021
• 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: RAINBOW M20-04 PATIENT CABLE; RAINBOW SUPER DCI MINI SENSOR