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

Model Number TDXSR-CG

Device Problems Break (1069); Battery Problem (2885); Noise, Audible (3273)

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 states that the devices left motor is making a grinding noise.The dealer states that during load test per our internal tech the batteries are dropping to around 15 volts.The dealer states that the cable to motors is damaged and the motor is intermittently shutting down.The patient is using their old chair.The dealer states it usually only fails if the stability lock flexes, going up his or ramps.

Manufacturer Narrative

The device was evaluated by the returns department which found that there was a cable failure.The chair has a right brake fault when the motor cable is flexed.

Event Description

The dealer states that the devices left motor is making a grinding noise.The dealer states that during load test per our internal tech the batteries are dropping to around 15 volts.The dealer states that the cable to motors is damaged and the motor is intermittently shutting down.The patient is using their old chair.The dealer states it usually only fails if the stability lock flexes, going up his or ramps.

• 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: 4990530
• MDR Text Key: 23910123
• Report Number: 1525712-2015-04210
• Device Sequence Number: 1
• Product Code: ITI
• 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
• Report Date: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TDXSR-CG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2015
• 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