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	06/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Per medwatch received: battery component of wrist band forcefully separated or exploded while in use on patient.No consequences or impact to patient were reported.
Additional Manufacturer Narrative
The returned device was evaluated.Visual inspection found the battery housing was separated and one battery was opened.The sensor passed continuity testing of the emitter and detector sites; however was unable to test device functionality due to the damaged sensor.Battery voltage testing could not be performed due to one opened battery and a non-functional battery pack.

• 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: 15126855
• Report Number: 3019388613-2022-00169
• Device Sequence Number: 6603646
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/05/2022

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: 11/01/2022
• Device Model Number: 4585
• Device Catalogue Number: 4585
• Device Lot Number: A20EJ18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2020
• 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