MAUDE Adverse Event Report: INVACARE TAYLOR STREET PRONTO M61; WHEELCHAIR, POWERED

Model Number 22NFMKG-2

Device Problems Crack (1135); Leak/Splash (1354); Out-Of-Box Failure (2311)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

The dealer states that the battery arrived to the dealer with a crack in the bottom of the box.The dealer states that the acid has all leaked out of the battery.The dealer states that this was a out of box failure.The dealer has no further information to provide.

• Brand Name: PRONTO M61
• 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: 4634341
• MDR Text Key: 5618866
• Report Number: 1525712-2015-02018
• 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: 03/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 22NFMKG-2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2015
• 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