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

Model Number 525

Device Problems Gas Output Problem (1266); Improper or Incorrect Procedure or Method (2017); Unintended Movement (3026)

Patient Problem Respiratory Distress (2045)

Event Date 12/27/2018

Event Type  Injury  

Manufacturer Narrative

This device was sold as a backup for a portable oxygen concentrator.The nuvo lite is not intended to be a life-support device.Upon receipt, the investigator noted the device had sustained quite a bit of handling damage and the unit had 18,494 hours of operation.There is no record of any service or maintenance to the device.The investigation concluded that a single fault component failure occurred, however, the alarm conditions performed as expected.

Event Description

"the patient was hospitalized as the backup stationary concentrator was not functioning and providing the patient oxygen.".

• Brand Name: 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
• MDR Report Key: 8323670
• MDR Text Key: 135684949
• Report Number: 1039215-2019-00002
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123738
• 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: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 525
• Device Catalogue Number: 525IN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Date Manufacturer Received: 01/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 79 YR