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

Model Number TPO100B

Device Problems Failure to Charge (1085); Device Emits Odor (1425)

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

Dealer advised enduser stated pulled the unit in for the night and when woke it was not charged and smelled a burnt smell but no physical damage.

Manufacturer Narrative

Additional/updated information was added to reflect the device being returned to the manufacturer for evaluation.However, the device was unable to be tested, so the original complaint issue was not able to be confirmed.

Event Description

As (b)(46 2015 power cord/converter was damaged.Dealer advised enduser stated pulled the unit in for the night and when woke it was not charged and smelled a burnt smell but no physical damage.

• 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: 5313438
• MDR Text Key: 34675071
• Report Number: 1031452-2015-17194
• 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: Replace
• Type of Report: Initial,Followup
• Report Date: 01/04/2016

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: 01/04/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/03/2015
• Initial Date FDA Received: 12/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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