MAUDE Adverse Event Report: GARDEN CITY MEDICAL ROLLATOR TALL ADULT M.BLUE 9153641189; WALKER, MECHANICAL

Model Number 1030KW

Device Problems Break (1069); Out-Of-Box Failure (2311)

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

Dealer is stating out of box failure, on one of the knee walkers is damaged on the seat and frame.

Manufacturer Narrative

The device was evaluated by the returns department which found that was a broken tack weld at the steering column.

Event Description

Dealer is stating out of box failure, on one of the knee walkers is damaged on the seat and frame.

• Brand Name: ROLLATOR TALL ADULT M.BLUE 9153641189
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): GARDEN CITY MEDICAL; 15 s. main st.; pmi - probasics - pinnacle; marlboro NJ 07746
• Manufacturer (Section G): GARDEN CITY MEDICAL; 15 s. main st.; pmi - probasics - pinnacle; marlboro NJ 07746
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4942901
• MDR Text Key: 22997082
• Report Number: 1125779-2015-00169
• Device Sequence Number: 1
• Product Code: ITJ
• 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: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1030KW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2015
• 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