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

Device Problems Device Stops Intermittently (1599); Improper or Incorrect Procedure or Method (2017)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/05/2016

Event Type  Injury  

Manufacturer Narrative

Client has polio and wears a leg brace on left leg which was broken in fall.Caregiver reminded to tell user to wear seatbelt at all times when using lift and to have assistance with use.Technician damaged osg during repair, so new osg fitted.Lift repaired and operating to spec.

Event Description

Upon descent, lift stopped at landing.Client tried to get off lift and fell down two steps and broke her left leg on which she wears a brace due to polio.

• Brand Name: ACORN 180 RH
• Type of Device: STAIRWAY CHAIRLIFT,
• Manufacturer (Section D): ACORN STAIRLIFTS, INC.; 7001 lake ellenor drive; orlando FL 32809
• Manufacturer Contact: tracy bero ; 7001 lake ellenor drive; orlando, FL 32809
• MDR Report Key: 6187380
• MDR Text Key: 62786034
• Report Number: 3003124453-2016-00008
• Device Sequence Number: 1
• Product Code: PCD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• 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
• Date Manufacturer Received: 11/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2011
• 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
• Treatment: LEG BRACE
• Patient Outcome(s): Hospitalization
• Patient Age: 78 YR