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U.S. Department of Health and Human Services

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

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NIDEK MEDICAL PRODUCTS, INC. MARK 5 NUVO LITE; OXYGEN CONCENTRATOR Back to Search Results
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.".
 
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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 Key7778827
MDR Text Key116960698
Report Number1039215-2018-00002
Device Sequence Number1
Product Code CAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123738
Number of Events Reported1
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 Number525
Device Catalogue Number525IN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/08/2018
Initial Date Manufacturer Received 08/02/2018
Initial Date FDA Received08/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/04/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age53 YR
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