MAUDE Adverse Event Report: HANDICARE 2000 CURVED STAIRLIFT; 2000 CURVED STAIRLFIT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

Outcome of investiagation is pending.A final report will be submitted upon completion.

Event Description

End use had their swivel release lever come unlocked while riding the unit.

• Brand Name: 2000 CURVED STAIRLIFT
• Type of Device: 2000 CURVED STAIRLFIT
• Manufacturer (Section D): HANDICARE; 82 first avenue; pensnett estate; kingswinford, DY67F J; UK DY67FJ
• Manufacturer (Section G): HANDICARE; 82 first avenue; pensnett estate; kingswinford, DY67F J; UK DY67FJ
• Manufacturer Contact: rekha janarthanan ; 10888 metro court; maryland heights, MO 63043 ; 3142198682
• MDR Report Key: 7466501
• MDR Text Key: 107207727
• Report Number: 3007802293-2018-00019
• 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: company representative,distri
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2018
• Initial Date FDA Received: 04/26/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1