MAUDE Adverse Event Report: PERMOBIL INC. LIFESTAND LSA HELIUM; MANUALLY PROPELLED STANDUP WHEELCHAIR

Model Number LSA HELIUM

Device Problem Break (1069)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/30/2018

Event Type  Injury  

Manufacturer Narrative

The end-user claims when the incident occurred, they were seated in the device with their legs being secured by the knee block assembly.As they were repositioning, the left side back frame broke causing the end-user to lose positioning and fall to the left side.As their legs were secured, it is speculated the leg twisted when their weight fell to the left side causing a reported proximal tibia/fibula fracture to the left leg.Review of photos supplied by the reporter indicate the left side of the back support frame broke in half.Review of the dhr indicates the device had previously been broken to where the right side seat frame needed replacement.Investigation shown that components to properly repair the device had been ordered, but had not been installed on the device prior to this reported event having occurred.Interviews with veterans administration physical therapist confirmed the end-user continued to utilize the device after being advised, on multiple occasions, to refrain from use and to utilize an alternative device until service could be completed.It is permobil's contention that with the end-user continuing to utilize the device in a diminished state, excessive forces were applied unevenly across the back frame, causing stress, leading to eventual material fatigue of the back frame material.As the device has exceeded 5 years in age, reports indicate the device is being evaluated for replacement vs.Repair.The dhr was reviewed and device met specification prior to distribution.

Event Description

Permobil received report claiming as end-user was repositioning itself in the seating, the left side back frame broke causing the end-user to lose positioning and fall to the side.It was reported the end-user had their legs secured to the device and when they fell to the side, caused a reported fracture to the left tibia and fibula.

• Brand Name: LIFESTAND LSA HELIUM
• Type of Device: MANUALLY PROPELLED STANDUP WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• Manufacturer (Section G): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• Manufacturer Contact: kevin bullock ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 8294464
• MDR Text Key: 134654899
• Report Number: 1221084-2019-00006
• Device Sequence Number: 1
• Product Code: IPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042596
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LSA HELIUM
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 77