MAUDE Adverse Event Report: NONIN MEDICAL, INC. 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	04/25/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
Nonin was contacted about retrieving the memory data out of the model 7500 pulse oximeter.It was communicated to us from the person who contacted us, the (mother) communicated that the child/patient is under nurse care and during monitoring the device alarmed but allegedly the nurse dismissed the alarm.There was a shift change in the nurses and the new nurse ended up calling 911.There is no allegation of any device malfunction.Nonin received the device as recommended so we could do the memory download for the mother 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.The device parameters were not set and were in default mode.The sensor that was utilized is not an approved sensor and is an off brand sensor that nonin does not manufacture.Model 7500 ifu states in the warning section, "to prevent improper performance and/or patient injury, verify compatibility of the monitor, sensor(s), and accessories before use." also, it states in the warning section, "to avoid patient injury, use only nonin-branded purelight® pulse oximeter sensors.These sensors are manufactured to meet the accuracy specifications for nonin pulse oximeters.Using other manufacturers' sensors can result in improper pulse oximeter performance." functional testing showed the device functioning as inteneded including 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.It was communicated to us from the person who contacted us, the (mother) communicated that the child/patient is under nurse care and during monitoring the device alarmed but allegedly the nurse dismissed the alarm.There was a shift change in the nurses and the new nurse ended up calling 911.There is no allegation of any device malfunction.

• Brand Name: NONIN MEDICAL MODEL 7500
• Common Device Name: PULSE OXIMETER
• Manufacturer (Section D): NONIN MEDICAL, INC.; 13700 1st avenue north; plymouth MN 55441 5443
• Manufacturer (Section G): NONIN MEDICAL, INC.; 13700 1st avenue north; plymouth MN 55441 5443
• Manufacturer Contact: dan labelle ; 13700 1st avenue north; plymouth, MN 55441-5443 ; 7635775507
• MDR Report Key: 17135713
• Report Number: 2183646-2023-00001
• Device Sequence Number: 6021238
• Product Code: DQA
• UDI-Device Identifier: 00833166009798
• UDI-Public: 00833166009798
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/15/2023

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: Health Professional
• Device Model Number: 7500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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