MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS XPO W/SUPPLEMENTAL BATTERY 9153648167; GENERATOR, OXYGEN, PORTABLE

Model Number XPO100B

Device Problems Out-Of-Box Failure (2311); Light Interference (2972)

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

Event Type  malfunction  

Manufacturer Narrative

A returned was issued and the product was evaluated upon receipt.A follow up will be filed if/when any additional information is provided.

Event Description

The dealer stated that he just received this unit from being repaired and it has no lights showing the liter flow.Out of box failure.

• Brand Name: XPO W/SUPPLEMENTAL BATTERY 9153648167
• 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: 5751935
• MDR Text Key: 48556617
• Report Number: 1031452-2016-02762
• 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: Initial
• Report Date: 06/06/2016

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: XPO100B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/06/2016
• Initial Date FDA Received: 06/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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