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

Model Number 525

Device Problem Insufficient Information (3190)

Patient Problems Respiratory Distress (2045); Low Oxygen Saturation (2477)

Event Date 07/22/2018

Event Type  Injury  

Manufacturer Narrative

Device returned to nidek on august 8, 2018.Device has no record of being serviced by nidek or any authorized service centers.Device had 23,557 hours of operation time.The evaluation summary concludes that the device passed all required tests and met applicable specifications.(b)(4).

Event Description

"hospitalization -> (b)(6) was notified.That the patient went to bed.With the nidek stationary device.The patient was found.Unresponsive and was transferred to the hospital via ambulance.The patient was intubated for approximately 12 hours and the physician stated that this was due to carbon dioxide built up in the blood.It was confirmed.That the patient was discharged from the hospital with a replacement unit.".

• 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
• MDR Report Key: 7778827
• MDR Text Key: 116960698
• Report Number: 1039215-2018-00002
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/13/2018

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: 525
• Device Catalogue Number: 525IN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Initial Date Manufacturer Received: 08/02/2018
• Initial Date FDA Received: 08/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2014
• 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: 53 YR