MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS PLATINUM 10 CONCEN W/SENS O2 9153642105; GENERATOR, OXYGEN, PORTABLE

Model Number IRC10LXO2

Device Problems Device Alarm System (1012); Out-Of-Box Failure (2311)

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

Event Type  malfunction  

Manufacturer Narrative

A follow up will be sent if the product or additional information is obtained.

Event Description

She states she received the unit back and out of the box, the unit will not alarm.She states the unit was set for a rental and when she was attempting to test the unit, the unit wouldn't alarm at start up and no sound.

Manufacturer Narrative

The device was evaluated by the returns department which found that the controls are defective.

Event Description

She states she received the unit back and out of the box, the unit will not alarm.She states the unit was set for a rental and when she was attampting to test the unit, the nit wouldn't alarm at start up and no sound.

• Brand Name: PLATINUM 10 CONCEN W/SENS O2 9153642105
• 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: 4973231
• MDR Text Key: 23747979
• Report Number: 1031452-2015-15286
• 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
• Report Date: 07/20/2015

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: IRC10LXO2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/05/2015
• 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
• Patient Outcome(s): Other