MAUDE Adverse Event Report: INVACARE TAYLOR STREET PRONTO M71 ACCESS. ATTACH KIT 9153637614; WHEELCHAIR, POWERED

Model Number M91

Device Problems Leak/Splash (1354); Failure to Align (2522)

Patient Problem No Information (3190)

Event Date 06/09/2015

Event Type  malfunction  

Event Description

Provider states the motors are leaking grease and chair is pulling to the left; no noise.

Manufacturer Narrative

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

• Brand Name: PRONTO M71 ACCESS. ATTACH KIT 9153637614
• 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: 4892073
• MDR Text Key: 6832106
• Report Number: 1525712-2015-03768
• 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
• Type of Report: Initial
• Report Date: 06/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M91
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2015
• 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
• Patient Outcome(s): Other