MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY O3 REGIONAL OXIMETER MODULE

Model Number	24668
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
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 that the o3 module provided inaccurate rso2 readings.No consequences or impact to patient were reported.
Event or Problem Description
The customer reported that the o3 module provided inaccurate rso2 readings.No consequences or impact to patient were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: the returned device was evaluated.External visual inspection found no damage or defects.During functionality testing the o3 sensor was placed in o3 regional oximetry diffuser fixture, measurements are not obtainable on either channel and an error message is displayed.Unable to perform accuracy test as the module cannot take measurements.The m12 connector was observed under a microscope and contamination was observed in the m12 connector pins.A service history record review reveals that this unit was in the field for over three (3) years with no previous reported issues related to this reported event.

• Brand Name: O3 REGIONAL OXIMETER MODULE
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 12178178
• Report Number: 3011353843-2021-00162
• Device Sequence Number: 19237887
• Product Code: MUD
• UDI-Device Identifier: 00843997010771
• UDI-Public: 00843997010771
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K033296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2021

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 Model Number: 24668
• Device Catalogue Number: 9637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1