MAUDE Adverse Event Report: ZHONGSHEN JUNCHENG INVACARE DUAL BLUE-RELEASE ADULT WALKER WITH 5" WHEELS; WALKER, MECHANICAL

Model Number 6240-5F

Device Problems Accessory Incompatible (1004); Break (1069); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/27/2017

Event Type  Injury  

Manufacturer Narrative

It has not yet been confirmed if the walker involved was in fact an invacare device.The model number, or any other product identification, has not been provided.Additionally, a product malfunction has not been confirmed.No details were provided regarding the alleged defect.The lawyer only stated that the incident was related to a "kneeler" that was added to the walker, which he implied was not an invacare component.More information has been requested from the patient's lawyer regarding the alleged involvement of the invacare walker.Should additional information become available, a supplemental record will be filed.

Event Description

A letter was received from a lawyer representing the patient in a claim for personal injuries (broken knee cap) arising as a result of a defective walker manufactured by invacare.

Manufacturer Narrative

The patient's lawyer sent photographs of the subject walker, which show that it is an invacare model 6240-5f.The photographs also show that the right rear leg of the walker is detached; it appears that the tubing broke at the hole where the rivet connects the cross brace to the side frame.Additionally, the photographs show a non-invacare "kneeler" mounted to the right side of the walker.The kneeler is a hanging knee sling that hooks onto the upper side frame of the walker to allow complete non-weight bearing patients to keep weight off their foot and ankle.However, by doing so, excessive weight is placed to one side of the walker.This uneven distribution of weight likely contributed to the walker tubing failure.The walker assembly, installation and operating instructions warn, "invacare products are specifically designed and manufactured for use in conjunction with invacare accessories.Accessories designed by other manufacturers have not been tested by invacare and are not recommended for use with invacare products." it also states, "make sure that the patient¿s weight is distributed evenly and directly over the walker legs.Do not hang anything on either the left or right side frames or the left and right slide tubes.This will cause side frames or slide tubes to bend and prevent the walker from locking when fully opened.This may also cause walker to tip, resulting in injury or damage." when the initial medwatch was submitted, the device manufacturer was unknown, so (b)(4) was used for invacare headquarters' location.However, the 6240-5f walker is manufactured in (b)(4) by (b)(4), and invacare is an importer of the device, so the (b)(4).

• Brand Name: INVACARE DUAL BLUE-RELEASE ADULT WALKER WITH 5" WHEELS
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): ZHONGSHEN JUNCHENG; no 69 zhao yi; dongsheng town; zhongshan, guangdong 52841 4; CH 528414
• MDR Report Key: 7299136
• MDR Text Key: 101028972
• Report Number: 1525712-2018-00028
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/13/2018,02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 6240-5F
• Device Lot Number: JC121105
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/13/2018
• Distributor Facility Aware Date: 02/27/2018
• Device Age: 4 YR
• Date Report to Manufacturer: 03/13/2018
• Initial Date Manufacturer Received: 02/06/2018
• Initial Date FDA Received: 02/27/2018
• Supplement Dates Manufacturer Received: 02/27/2018
• Supplement Dates FDA Received: 03/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other