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

Model Number 525

Device Problems No Audible Alarm (1019); No Flow (2991)

Patient Problem Adult Respiratory Distress Syndrome (1696)

Event Type  malfunction  

Manufacturer Narrative

Device serviced by nidek medical on 9/28/16 at 9,679.7 operational hours.After servicing, device was returned to inogen meeting all required specifications.After reported event, the device was returned with 23,296 operational hours.Nidek requested servicing information from inogen and was informed "we (inogen) actually do not provide any service to these types of units - we simply do oxygen purity checks when the units are received in house.If the units fail the o2 purity check then we simply scrap the unit out of the system".Nidek has not received requested information.The evaluation summary concludes the device was not operating within specifications (low oxygen concentration) but that all alarms and safety features are operational.

Event Description

"the patient was hospitalized as it was indicated that the stationary nidek was not putting out oxygen.Per the patient, the unit did not alarm.".

• 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: 7635708
• MDR Text Key: 112752324
• Report Number: 1039215-2018-00001
• 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: Other
• Type of Report: Initial
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• 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
• Device Lot Number: 23544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2014
• 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): Hospitalization
• Patient Age: 62 YR