MAUDE Adverse Event Report: DOLOMITE AB DOLOMITE MAXI ROLLATOR 650 7331492560417; WALKER, MECHANICAL

Model Number 12076-43-27

Device Problems Mechanical Problem (1384); Material Too Rigid or Stiff (1544); Device Operates Differently Than Expected (2913)

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

Event Date 02/09/2015

Event Type  malfunction  

Event Description

The locking device in 5 new delivered futura 680 doesn´t work.It lock, but it doesn´t click like it usually does.A theory from the product specialist is that the locking mechanism is not adjusted correct and that the spring in the handle is bad.It feels very different then it usually does.It feels inelastic.The product are already at rea.It reads, but it will not click in that it usually does.Believe that the locking mechanism can be aligned and that the spring sitting of the handle is disposed.It feels very different.It feels rigid.

Manufacturer Narrative

The futura is the same /similar to a product or products which are, or have been manufactured and/or marketed by invacare in u.S.The alleged incident occurred in (b)(6).

• Brand Name: DOLOMITE MAXI ROLLATOR 650 7331492560417
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): DOLOMITE AB; vaxjovagen 303; 343 75 dio ; SW
• Manufacturer (Section G): DOLOMITE AB; vaxjovagen 303; 343 75 dio ; SW
• Manufacturer Contact: kevin guyton
• MDR Report Key: 4568319
• MDR Text Key: 5553842
• Report Number: 9615290-2015-00092
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 02/09/2015

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: 12076-43-27
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/09/2015
• Initial Date FDA Received: 03/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other