MAUDE Adverse Event Report: DRIVE MEDICAL DRIVE MEDICAL; WALKER PLATFORM ATTACHMENT

Device Problems Bent (1059); Device Unsafe to Use in Environment (2918)

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

Event Type  Injury  

Event Description

Background.Walker platform attachment issues reported by pts at (b)(6).Summary.Upon testing, the platform attachment is bending to the point that the metal attachment may split, making them unfit for patient use.During testing, the attachments were tightly secured and tested with weights well below the 300 lb capacity.Testing reports provided by pts at (b)(6).Testing also completed by (b)(6) pts.(b)(6) currently does not have walker platform attachments to provide to patient upon discharge as the equipment was deemed unfit for patients by their pts.Pts are providing platform attachments from the hospital or will request a home care coordinator to deliver a walker to the patient's home from another vendor.No patient harm as the patients have been discharged with the equipment.One incident report case entered.Scope: reports from pts at (b)(6) as well as (b)(6) hospital.Investigation: a platform walker attachment should carry 300 lbs.The platform should be bent 90 degrees and parallel to the ground.After a (b)(6) lb pt from (b)(6) tested the attachment, the platform bent to below 90 degrees.Identifiers on defective wheelchair saved by (b)(6) pt: drive manufacturer response (drive business manager): concern reported by other drive customers and, upon investigation, the attachments were not installed correctly, specifically regarding how tightly the equipment is screwed together.Testing by (b)(6) pts: pts found that, although the screws were tight and fully secure, the metal seemed to be flimsy and could easily snap with further weight applied to the platform.Patients who use the platform attachments will place all their weight on the attachments making the drive platforms unfit for patient use.Conclusion and next steps: drive walker platform attachments are not appropriate for patient use and should be pulled from inventory.Director of risk management to identify next steps in terms of reporting to (b)(4) or fda.Need long-term corrective action regarding inventory.

• Brand Name: DRIVE MEDICAL
• Type of Device: WALKER PLATFORM ATTACHMENT
• Manufacturer (Section D): DRIVE MEDICAL
• MDR Report Key: 7137417
• MDR Text Key: 95583499
• Report Number: MW5074129
• 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: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2017

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention