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  

Manufacturer Narrative

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

Event Description

The dealer stated that the display is not functional but the unit is working.

Manufacturer Narrative

Additional/updated information was added to reflect the device being returned to the manufacturer for evaluation.The result of the evaluation was that the lcd display board was broken due to physical damage, which confirmed the original complaint issue.

Event Description

The dealer stated that the display is not functional but the unit is working.

• 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: 5828788
• MDR Text Key: 50663600
• Report Number: 1031452-2016-03129
• 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: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 08/17/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/06/2016
• Initial Date FDA Received: 07/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/24/2016
• 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