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

Model Number 905-003NSH

Device Problems Material Perforation (2205); Cut In Material (2454); Issue With Displayed Error Message (2967)

Patient Problem Pulmonary Dysfunction (2019)

Event Date 02/18/2014

Event Type  malfunction  

Event Description

Patient complained of difficulty breathing and was taken to the er.

Manufacturer Narrative

The unit was repaired by nsh and the defective part was returned to nidek medical for evaluation.A cut/torn gasket in the air transport system interfered with the function of a valve in the assembly.

• Brand Name: MARK 5 NUVO
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): NIDEK MEDICAL PRODUCTS, INC.; birmingham
• Manufacturer (Section G): NIDEK MEDICAL PRODUCTS, INC.; 3949 valley east industrial dr; birmingham AL 35217
• Manufacturer Contact: randy scott ; 3949 valley east industrial dr; birmingham, AL 35217 ; 2058567200
• MDR Report Key: 3786375
• MDR Text Key: 4441641
• Report Number: 1039215-2014-00002
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative,Distributor
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 02/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 905-003NSH
• Device Catalogue Number: 905-003NSH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2013
• 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 Age: 81 YR