MAUDE Adverse Event Report: DOLOMITE AB ROLLATOR 9153651315; WALKER, MECHANICAL

Model Number JAZZSTD

Device Problems Device Slipped (1584); Material Protrusion/Extrusion (2979)

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

Event Type  malfunction  

Event Description

Provider states brakes popping up.Will not stay locked, replacing cable.Additional reportable malfunction for this device; (b)(6) - brake handle issue.

Event Description

Provider states brakes popping up.Will not stay locked, replacing cable.Additional reportable malfunction for this device; (b)(6)- brake handle issue.

Manufacturer Narrative

(b)(4) - initial mfg report # 9615290-2015-00122 was submitted to the fda on 03/26/2015 in error.This event was submitted to the fda under mfg.Report # 9616290-2015-00121 on 03/26/2015.There was a brake issue on the rollator that required 2 parts to be replaced to fix the issue, the brake handle and the brake wire cover.Only 1 mdr needed to be submitted.

• Brand Name: ROLLATOR 9153651315
• 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 ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4634989
• MDR Text Key: 5614861
• Report Number: 9615290-2015-00122
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 03/13/2015

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: JAZZSTD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2015
• Initial Date FDA Received: 03/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/27/2015
• 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