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

Model Number XPO100B

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2015 a return was issued and the product is awaiting receipt and/or evaluation.A follow up will be filed if/when any additional information is provided.

Event Description

Dealer states that the unit was in on rma 864797323 prid 388533 , states that the line that plugs into the battery outlet the black and white wires are exposed.

Manufacturer Narrative

The result of the evaluation was that the wiring harness was disconnected due to physical damage and the connecter was damaged, which confirmed the original complaint issue.However, the underlying cause could not be determined.

Event Description

Dealer states that the unit was in on rma 864797323 prid 388533, states that the line that plugs into the battery outlet the black and white wires are exposed.

• 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: 5238642
• MDR Text Key: 31997485
• Report Number: 1031452-2015-16837
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 01/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2015
• 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: 01/23/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2016
• 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