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

Model Number XPO100B

Device Problem No Display/Image (1183)

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

Event Date 10/19/2015

Event Type  malfunction  

Manufacturer Narrative

Should additional information become available, a supplemental record will be filed.

Event Description

Provider states the unit lights will not display and was not able to determine the issues.

Manufacturer Narrative

Product was returned for evaluation.The return fields in oracle state: portable concentrators.Other, other/defective.Sieve bed, other/defective.Unit had a defective control panel, no lights.Estimate declined - scrap.Complaint of "unit lights will not display " was confirmed.The underlying cause is defective control panel.Root cause could not be determined after reviewing the documentation in this investigation.

Event Description

Product was returned for evaluation.The return fields in oracle state: portable concentrators.Other, other/defective.Sieve bed, other/defective.Unit had a defective control panel, no lights.Estimate declined - scrap.Provider states the unit lights will not display and was not able to determine the issues.

• 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: 5219673
• MDR Text Key: 31215752
• Report Number: 1031452-2015-16702
• 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,Followup
• Report Date: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2015
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/03/2015
• 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