MAUDE Adverse Event Report: NIDEK MEDICAL PRODUCTS, INC. MARK 5 NUVO LITE; OXYGEN CONCENTRATOR

Model Number 925

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn(s) (1757)

Event Type  Death  

Manufacturer Narrative

The manufacturer received information alleging an oxygen concentrator was involved in a house fire.A photograph from the scene was provided and suggested that smoking occurred in the patient's home.Product labeling states "this device supplies highly concentrated oxygen enriched product gas that promotes rapid burning.Do not allow smoking or open flames within the same room of this device or the administration accessory (cannula).Failure to observe this warning can result in severe fire, property damage, and / or cause physical injury or death." this incident is currently under investigation and should any additional information be provided, a follow up report will be submitted.

Event Description

Distributor in greece received notification of a device that was involved in a house fire.Device has not been returned as there is an open fire investigation.There was property damage and the patient died.

• Brand Name: MARK 5 NUVO LITE
• Type of Device: OXYGEN CONCENTRATOR
• Manufacturer (Section D): NIDEK MEDICAL PRODUCTS, INC.; 3949 valley east industrial dr; birmingham AL 35217
• Manufacturer (Section G): NIDEK MEDICAL PRODUCTS, INC.; 3949 valley east industrial dr; birmingham AL 35217
• Manufacturer Contact: olivia mullen ; 3949 valley east industrial dr; birmingham, AL 35217 ; 2058567200
• MDR Report Key: 11793906
• MDR Text Key: 249612616
• Report Number: 1039215-2021-00001
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K123738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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 Operator: Lay User/Patient
• Device Model Number: 925
• Device Catalogue Number: 925
• Device Lot Number: 36194
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/29/2021
• Initial Date FDA Received: 05/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2018
• 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: 86 YR