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

Model Number XPO100B

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Dealer states the unit has a broken display.

Manufacturer Narrative

Product was returned for evaluation.The return fields in oracle state: portable concentrators.Other, other/defective.Sieve bed, saturated.Battery, not holding charge.Unit had defective control panel, repoured sieve beds, replaced caps, seals, tubing.Complaint of "broken 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, saturated.Battery, not holding charge.Unit had defective control panel, repoured sieve beds, replaced caps, seals, tubing.Dealer states the unit has a broken display.

• 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: 5267027
• MDR Text Key: 32933609
• Report Number: 1031452-2015-17000
• 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: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• 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: 12/21/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2015
• 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