MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS XPO2 PORTABLE CONCENTRATOR 9153648166; GENERATOR, OXYGEN, PORTABLE

Model Number XPO100 B

Device Problems No Audible Alarm (1019); Sticking (1597)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Product has not been returned for evaluation as of the date of this investigation.Rma was issued.If new information becomes available at a later date this complaint will be updated and/or a follow up be sent.

Event Description

Per provider, concentrator is stuck at 5 liters and the minus button to change the liters is not working.Unit is not alarming and there are no indicator lights on the unit.

Manufacturer Narrative

The device was evaluated by the returns department which found that the controls switch/button is broken, the sieve bed is saturated, and the sieve bed's cap/o-ring/gasket is leaking.

Event Description

Per provider, concentrator is stuck at 5 liters and the minus button to change the liters is not working.Unit is not alarming and there are no indicator lights on the unit.

• Brand Name: XPO2 PORTABLE CONCENTRATOR 9153648166
• 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: 5045549
• MDR Text Key: 25298274
• Report Number: 1031452-2015-15768
• 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: 08/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: XPO100 B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2015
• 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