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

Model Number LSA HELIUM

Device Problems Labelling, Instructions for Use or Training Problem (1318); Unintended Movement (3026)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/12/2016

Event Type  Injury  

Manufacturer Narrative

The end-user reported having just performed a side transfer into the lifestand helium from another manual wheelchair and were positioned at the front edge of the seating.The end-user described putting their hands at the sides to lift their body to reposition farther back into the seating.While performing this act, the end-user reports the seating went into a stand position which caused them to lose their balance and fall to the floor.End-user reported having called emergency services to where they were transported to the local hospital for evaluation.End-user was diagnosed as suffering distal fractures to both femurs requiring surgery.The wheelchair was evaluated, and the manual stand feature mechanics were found operating according to specification.End-user was questioned as to if they had received any instruction, prior to use, covering the need to engage the safety locks which would prevent unintentional activation of stand when in the seated position.The end-user claimed having no recollection of having received that instruction, but testimony from the service provider and area sales representative differ.Based upon the lack of evidence to support a product malfunction, root cause is being considered user error.The dhr was reviewed and device met specification prior to distribution.Note: permobil had received initial report in june 2016 but was unable to determine failure mode, assignable cause or confirm the extent of injury alleged.Multiple attempts were made by permobil counsel to gather more information but went unsuccessful and the case was closed due to lack of evidence.On october 9th, 2018, permobil received information from outside counsel which provided detail into the allegations presented.

Event Description

Permobil received a letter of intent claiming an incident having occurred involving a lifestand helium manual wheelchair.Letter alleged the end-user of the device was injured but did not provide any details as to what had occurred, or to the extent of the injuries sustained.Note: on 10/9/2018, permobil was made aware of serious injury from which the patient broke both femur bones and requiring surgery on both legs.

• 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: 8047139
• MDR Text Key: 126419176
• Report Number: 1221084-2018-00070
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• 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
• Date Manufacturer Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2014
• 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