MAUDE Adverse Event Report: ACORN MOBILITY SERVICES LTD ACORN STAIRLIFT; STAIRWAY CHAIRLIFT

Model Number 180

Device Problems Break (1069); Crack (1135); Defective Component (2292)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/27/2016

Event Type  malfunction  

Event Description

Customer called that whilst dismounting stairlift at bottom of stairway seatbase snapped off.

• Brand Name: ACORN STAIRLIFT
• Type of Device: STAIRWAY CHAIRLIFT
• Manufacturer (Section D): ACORN MOBILITY SERVICES LTD; telecom house; millenium business park; steeton, west yorkshire BD20 6RB; UK BD20 6RB
• Manufacturer Contact: william waddell ; telecom house; millenium business park; steeton, west yorkshire BD20 -6RB ; UK BD20 6RB ; 053291000
• MDR Report Key: 5590004
• MDR Text Key: 43174030
• Report Number: 3006310491-2016-00002
• Device Sequence Number: 1
• Product Code: PCD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2016
• Date Manufacturer Received: 02/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 81 YR