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

Model Number 905

Device Problems Thermal Decomposition of Device (1071); Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturer received information alleging an oxygen concentrator had evidence of thermal damage.The serial number of the device was included in a previously closed field correction.Records show sending replacement part to distributor, however there is no confirmation that the part was actually replaced.Based on information provided, the event was likely caused by the defective component.No indication of harm to the patient, nor property damage.This report is being filed out of an abundance of caution, as this issue has already been investigated.

Event Description

Distributor in (b)(4) received notification of a device with thermal damage.Device was picked up by distributor, photographed and then discarded.There is no mention of harm to patient or their home.

• Brand Name: MARK 5 NUVO
• 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
• MDR Report Key: 10885720
• MDR Text Key: 217708190
• Report Number: 1039215-2020-00001
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K040892
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 905
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2007
• 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