MAUDE Adverse Event Report: INVACARE TAYLOR STREET POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI; WHEELCHAIR, POWERED

Model Number TDXSP-MCG

Device Problems Device Emits Odor (1425); Smoking (1585)

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

Consumer plugged the charger in then a puff of smoke came out and they then smelled a sulfer smell.

Manufacturer Narrative

Additional/updated information was added to reflect the charger being returned for evaluation.Subsequent testing verified the complaint of the unit having smell, but the complaint of the unit smoking could not be confirmed.Per the initial evaluation, a smell was noticed coming from the vent holes when the power was not on.Additionally, the ac receptacle was slightly pushed into the housing.The unit powered up normally; however, the output voltage increased to 28.85 volts with the empty light lit.An expanded evaluation was performed.Per the expanded evaluation report, no evidence of smoke, burning, or any odor was found in or on the charger.The connection for the power cable was confirmed to be slightly pushed into the unit, but it was still able to be accessed and used.The charger was powered on and connected to a test joystick and two batteries.The initial voltage of the batteries was measured at 21.81 vdc, and the amber light on the charger was lit, indicating that the batteries were empty.The charger was then allowed to charge the batteries overnight.After charging, the voltage of the batteries was measured at 27.26 vdc, and the green light on the charger was lit, indicating the batteries were ready and charged.Therefore, the charger worked as intended to charge the batteries.

Event Description

Consumer plugged the charger in then a puff of smoke came out and they then smelled a sulfur smell.

• Brand Name: POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5340744
• MDR Text Key: 35279122
• Report Number: 1525712-2015-05974
• Device Sequence Number: 1
• Product Code: IOR
• 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: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TDXSP-MCG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2016
• 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