MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS PLATINUM 10 CONCENTRATOR 9153642104; GENERATOR, OXYGEN, PORTABLE

Model Number IRC10LX

Device Problems Device Alarm System (1012); Gas Output Problem (1266)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/28/2015

Event Type  malfunction  

Manufacturer Narrative

Should additional information become available for the patient a supplemental record will be filed.

Event Description

Dealer advised low o2 with yellow light and no alarm.

Manufacturer Narrative

Ther device was evaluated and it was determined that the manifold pilot valve is defective.

Event Description

Dealer advised low o2 with yellow light and no alarm.

• Brand Name: PLATINUM 10 CONCENTRATOR 9153642104
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): INVACARE FLORIDA OPERATIONS; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer (Section G): INVACARE FLORIDA OPERATIONS; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5116127
• MDR Text Key: 27263178
• Report Number: 1031452-2015-16119
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Followup
• Report Date: 10/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRC10LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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