MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS SOLO2 TRANSPORTABLE OXYGEN CONCENTRATOR 9153650707; GENERATOR, OXYGEN, PORTABLE

Model Number TPO100B

Device Problem No Display/Image (1183)

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

Event Type  malfunction  

Event Description

Dealer is stating that the unit screen has no display.

Manufacturer Narrative

The product was returned on 6/29/2015 for evaluation.The results of the return evaluation were not available for review at the time of this investigation.If new information becomes available at a later date this complaint will be updated &/or a follow up be sent.

Manufacturer Narrative

The device was evaluated by the returns department which found that lcd pcb display is damaged and the cabinet is fractured/cracked.

Event Description

Dealer is stating that the unit screen has no display.

• Brand Name: SOLO2 TRANSPORTABLE OXYGEN CONCENTRATOR 9153650707
• 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: 4919327
• MDR Text Key: 6049588
• Report Number: 1031452-2015-14899
• 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,distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 07/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TPO100B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/25/2015
• 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