MAUDE Adverse Event Report: NONIN MEDICAL, INC. NONIN PULSE OXIMETER

Model Number 7500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 11/23/2020

Event Type  Death  

Manufacturer Narrative

An incident was reported that a patient went into cardiac arrest at their home, was then transported to the emergency room and subsequently passed away.A model 7500 pulse oximeter was present at the patient's home at the time of cardiac arrest.At the time that the incident was reported, there was no indication that the model 7500 pulse oximeter caused or contributed to patient injury or death.It was reported that the infant patient had underlying health conditions and was on a ventilator at the time of cardiac arrest.Nonin medical requested the model 7500 pulse oximeter be returned for evaluation to confirm that the device was operating according to specification.The dme received the equipment from the facility but has declined to return the device to nonin medical pending the dme's legal investigation of the event as a whole.At this time, there has been no indication or allegation of device malfunction contributing to the reported event.Nonin medical remains in close contact with the dme and will continue monitoring for similar events to ensure the product continues to perform as expected.

Event Description

An incident was reported that a patient went into cardiac arrest at their home, was then transported to the emergency room and subsequently passed away.A model 7500 pulse oximeter was present at the patient's home at the time of cardiac arrest.At the time that the incident was reported, there was no indication that the model 7500 pulse oximeter caused or contributed to patient injury or death.It was reported that the infant patient had underlying health conditions and was on a ventilator at the time of cardiac arrest.

• Brand Name: NONIN PULSE OXIMETER
• Type of Device: PULSE OXIMETER
• Manufacturer (Section D): NONIN MEDICAL, INC.; 13700 1st ave. n.; plymouth MN 55441
• Manufacturer (Section G): NONIN MEDICAL, INC.; 13700 1st ave. n.; plymouth MN 55441
• Manufacturer Contact: alex nelson ; 13700 1st ave. n.; plymouth, MN 55441 ; 6513804305
• MDR Report Key: 11124728
• MDR Text Key: 225322020
• Report Number: 2183646-2021-00001
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00833166009798
• UDI-Public: 00833166009798
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080255
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7500
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 19 MO