MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY O3 INFANT AND NEONATAL SENSOR; OXIMETER

Model Number	4384
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
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.Device not returned.
Event or Problem Description
The customer reported the sensor lifted off the patient during use causing the measured values to increase.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: the returned sensor was evaluated.During evaluation the sensor passed all visual and functional testing.  during simulation testing, the sensor passed manual and preset conditions and provided accurate measurements.The sensor was determined to be functioning as designed.  .
Event or Problem Description
The customer reported the sensor lifted off the patient during use causing the measured values to increase.No patient impact or consequences were reported.

• Brand Name: O3 INFANT AND NEONATAL SENSOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 11959965
• Report Number: 3011353843-2021-00130
• Device Sequence Number: 3648827
• Product Code: MUD
• UDI-Device Identifier: 10843997013496
• UDI-Public: 10843997013496
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2021

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: 12/01/2023
• Device Model Number: 4384
• Device Catalogue Number: 4384
• Device Lot Number: 20NDH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1