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

Model Number TPO100B

Device Problems Melted (1385); Device Displays Incorrect Message (2591)

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

Record 1 of 2.Dealer advised enduser contacted him about two months ago and had issues in the car with unit.Dealer advised top part of the dc adapter that goes into the car plug is melted.Dealer advised provided another one for the enduser and the same thing happened.Dealer advised enduser stated has no problem with ac adapter.Dealer advised unit showing low o2 fluctuating from 90.3 to 89.1 with yellow light.Dealer advised will send unit in for repair.

Manufacturer Narrative

Additional/updated information was added to reflect the device being returned to the manufacturer for evaluation.The dc adapter was returned for evaluation, and subsequent testing verified the complaint of it melting.Per the initial evaluation, the dc adapter was melted where it plugs into the power source.An expanded evaluation was performed.Per the expanded evaluation report, the dc adapter cord was in good condition without any nicks or cuts; however, the portion of the adapter that plugs into the car port had been plastically deformed, which was evidence of melting.It was noted that the adapter was an older design and that the melting issue has already been addressed by dc1221046 ((b)(4)).This capa addresses the solo2 automotive power supply's power plug that is inserted into the cigarette lighter/power port within a vehicle that has been identified as overheating, smoking, or melting due to a stack up of internal assembly contact resistances.Additionally, the concentrator was returned for evaluation and repair, and subsequent testing verified the complaint of low o2.The underlying cause was identified as the pcb oxygen sensor was defective, causing the yellow light to illuminate.Also, the compressor had low output, the manifold was leaking, and the sieve beds were saturated, contributing to the low o2.

Event Description

Record 1 of 2.Dealer advised enduser contacted him about two months ago and had issues in the car with unit.Dealer advised top part of the dc adapter that goes into the car plug is melted.Dealer advised provided another one for the enduser and the same thing happened.Dealer advised enduser stated has no problem with ac adapter.Dealer advised unit showing low o2 fluctuating from 90.3 to 89.1 with yellow light.Dealer advised will send unit in for repair.

• 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: 5343049
• MDR Text Key: 35347900
• Report Number: 1031452-2016-00012
• 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: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2016
• 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: 01/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2016
• 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