MAUDE Adverse Event Report: GARDEN CITY MEDICAL TALL ADULT WALKLITE WALKER 9153643781; WALKER, MECHANICAL

Model Number 1030KW

Device Problems Loose or Intermittent Connection (1371); Device Unsafe to Use in Environment (2918)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Dealer is stating that they just sold the unit with in the last 4 weeks, and the end user after a few days of use, the unit is really loose.Dealer and end user feel it is unsafe to use.No other information provided.

Manufacturer Narrative

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

Manufacturer Narrative

Product was returned for evaluation.The return fields in oracle state: frame/structure, frame bent, tiller steering column bent.Complaint of unit is really loose was confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.Serial number added to complaint from return of product.

Event Description

Product was returned for evaluation.The return fields in oracle state: frame/structure, frame bent, tiller steering column bent.Dealer is stating that they just sold the unit with in the last 4 weeks, and the end user after a few days of use, the unit is really loose.Dealer and end user feel it is unsafe to use.No other information provided.

• Brand Name: TALL ADULT WALKLITE WALKER 9153643781
• 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: 4881320
• MDR Text Key: 6057368
• Report Number: 1125779-2015-00124
• 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,distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 10/07/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2015
• Initial Date FDA Received: 07/01/2015
• 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