MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RADIUS PPG NEO; OXIMETER

Model Number	4585
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Per medwatch received: "battery compartment on wrist device forcefully separated while in use on patient." no consequences or impact to patient were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: the returned device was evaluated.Visual inspection found the sensor housing has separated.Battery voltage testing unavailable because the white portion of sensor housing (including batteries) was not received for investigation.No short or open was detected, and no intermittent short or open was detected when sensor is manipulated.Unable to test device functionality due to damaged sensor.

• Brand Name: RADIUS PPG NEO
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 15750 ALTON PKWY; 15750 alton pkwy; irvine CA 92618
• Manufacturer (Section G): MASIMO - MEXICALI; industrial vallera de mexicali calzada del oro, no.2001; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: matofa fautua ; 15750 alton pkwy; irvine, CA 92618 ; 9498223661
• MDR Report Key: 15332428
• Report Number: 3019388613-2022-00195
• Device Sequence Number: 17874566
• Product Code: DQA
• UDI-Device Identifier: 10843997014684
• UDI-Public: 10843997014684
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K183697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/19/2022

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: 05/01/2024
• Device Model Number: 4585
• Device Catalogue Number: 4585
• Device Lot Number: 22EWY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RADIUS PPG REUSABLE CHIP.
• Patient Sex: Unknown