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	12/04/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
Nonin was contacted about retrieving the memory data out of the model 7500 pulse oximeter from our customer who purchased the device (dme).A pediatric baby died who was on a ventilator and also the pulse oximter.It was communicated to us that the father went into start feeds at 10pm on december 4th and found baby unresponsive.No other information was provided when requested.There is no allegation of any device malfunction.Nonin received the device as recommended so we could do the memory download as requested.We also did an investigation by inspecting the device, performing functional testing and performance testing.The device date and time was not set.Patient security mode was set at 87% spo2, heart rate 200 upper and 60 lower, audible alarm was set at low.Test report# (b)(4) was documented.Functional testing verified device functions and meets nonin specification including visual and audible alarms.Performance testing of the device was performed (low perfusion per iso 80601-2-61: 2017 sub-clauses 201.12.1.103 & 201.12.1.104) resulting in a pass.Nonin will continue monitoring for similar events to ensure the device continues to perform as expected.
Event or Problem Description
Nonin was contacted about retrieving the memory data out of the model 7500 pulse oximeter from our customer who purchased the device (dme).A pediatric baby died who was on a ventilator and also the pulse oximter.It was communicated to us that the father went into start feeds at 10pm on december 4th and found baby unresponsive.No other information was provided when requested.There is no allegation of any device malfunction.

• 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: dan labelle ; 13700 1st avenue north; plymouth, MN 55441-5443 ; 7635775507
• MDR Report Key: 18456061
• Report Number: 2183646-2024-00001
• Device Sequence Number: 14228127
• 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): N
• 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): 01/05/2024

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
• Operator of Device: Other
• Device Model Number: 7500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2023
• Initial Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2023
• 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: Female