MAUDE Adverse Event Report: ACORN STAIRLIFTS, INC. ACORN 180 LH; POWER STAIRWAY CHAIRLIFT

Device Problems Device Maintenance Issue (1379); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problems Bone Fracture(s) (1870); Laceration(s) (1946); Fracture, Arm (2351)

Event Date 10/18/2017

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2017 the customer attempted to ride the stairlift to go upstairs but the unit would not move from its position at the bottom charge point.After trying to use the lift the customer attempted to walk up the stairs.On the second step up from the mid-landing she lost her footing and fell backwards down the stairs to the foyer.The fall resulted in multiple injuries.The incident occurred on (b)(6) 2017 but was not reported to acorn until (b)(6) 2018.Between those two dates the lift was unmoved but was turned off by the customer's son-in-law to stop the beeping.The lift was off and uncharged for several months; because of this the root cause could not be adequately determined.The most likely underlying cause was the excess lubricant on the charge pins.The dirt buildup that resulted from the excess lubricant caused continuity issues within the charging circuit so the lift would not charge properly rendering it inoperable.During the (b)(6) 2018 product evaluation; the excess lubricant was removed and the charge pins were cleaned and re-greased.The carriage was also replaced as a courtesy and so acorn could further evaluate the equipment.

Event Description

The customer attempted to use the lift to go upstairs, but was not able to get the lift to move off the bottom charge point.There was too much lubricant on the charge pins preventing the lift from fully charging.The customer decided to walk up the stairs since the lift was not working.When she reached the second landing she lost her footing and fell down the stairs to the foyer.The fall resulted in multiple injuries.

• Brand Name: ACORN 180 LH
• Type of Device: POWER STAIRWAY CHAIRLIFT
• Manufacturer (Section D): ACORN STAIRLIFTS, INC.; 7001 lake ellenor drive; orlando FL 32809 5792
• Manufacturer Contact: tracy bero ; 7001 lake ellenor drive; orlando, FL 32809-5792 ; 4076500216
• MDR Report Key: 7238415
• MDR Text Key: 98915729
• Report Number: 3003124453-2018-00001
• Device Sequence Number: 1
• Product Code: PCD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 02/02/2018

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/03/2018
• Initial Date FDA Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2015
• 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): Hospitalization
• Patient Age: 84 YR
• Patient Weight: 84