MAUDE Adverse Event Report: NONIN MEDICAL NONIN MEDICAL MODEL 7500; PULSE OXIMETER

Model Number	7500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/26/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Nonin medical was contacted 8/21/2025 requesting the data download from the model 7500 device that we manufacture.It was communicated that the patient passed away and the detectives are requesting the data and specifically looking for on (b)(6) 2025.No allegation of device malfunction.No other information was provided to nonin medical except that nothing has been reported and that the device was not malfunctioning.It was alarming and the nurse did not respond.Originally communicated that the device was going to be returned to nonin medical for the data download but then later communicated that the device will be sent to their own biomed for data download.No other information was communicated or shared with nonin medical despite numerous requests.
Event or Problem Description
Nonin medical was contacted 8/21/2025 requesting the data download from the model 7500 device that we manufacture.It was communicated that the patient passed away and the detectives are requesting the data and specifically looking for on (b)(6) 2025.No allegation of device malfunction.No other information was provided to nonin medical except that nothing has been reported that the device was not working.It was alarming and the nurse did not respond.

• Brand Name: NONIN MEDICAL MODEL 7500
• Common Device Name: PULSE OXIMETER
• Manufacturer (Section D): NONIN MEDICAL; 13700 1st avenue north; plymouth MN 55441 5443
• Manufacturer (Section G): NONIN MEDICAL; 13700 1st avenue north; plymouth MN 55441 5443
• Manufacturer Contact: mr. labelle ; 13700 1st avenue north; plymouth, MN 55441-6443 ; 7635775507
• MDR Report Key: 23057182
• Report Number: 2183646-2025-00001
• Device Sequence Number: 9503757
• Product Code: DQA
• UDI-Device Identifier: 00833166009798
• UDI-Public: 00833166009798
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K080255
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 7500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown