MAUDE Adverse Event Report: NIDEK MEDICAL PRODUCTS, INC. MARK 5 NUVO 8; OXYGEN CONCENTRATOR

Model Number 985UK

Device Problems Device Damaged Prior to Use (2284); Failure to Deliver (2338)

Patient Problems Chest Pain (1776); Respiratory Distress (2045)

Event Date 07/22/2016

Event Type  malfunction  

Manufacturer Narrative

Upon inspection, it was determined the device was damaged due to abnormal use (i.E.Broken regulator).

Event Description

"oxygen had stopped flowing through the concentrator.The concentrator did not alarm to make the patient aware.The patient was aware that he was not well.His wife reported that he had cold extremities, chest pain and was grey in colour.The motor of the concentrator was still running but it was no alarming visually or audibly." (b)(4).

• Brand Name: MARK 5 NUVO 8
• 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: randy scott ; 3949 valley east industrial dr; birmingham, AL 35217 ; 2058567200
• MDR Report Key: 5974030
• MDR Text Key: 55568279
• Report Number: 1039215-2016-00002
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K093308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Nurse
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 985UK
• Device Catalogue Number: 985UK
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2015
• 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
• Treatment: OXYGEN CYLINDER
• Patient Outcome(s): Required Intervention