MAUDE Adverse Event Report: HANDICARE B/LIFT HANDSET 5 RETRO US; BATHLIFT HAND CONTROL

Model Number 311

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem Distress (2329)

Event Date 03/14/2014

Event Type  malfunction  

Event Description

The bathlift was used by the customer in the tub.The bathlift operated correctly lowering into the tub by depressing the down button on the hand control.When required to rise up out of the tub through operation of the up button on the hand control, the bathlift would not operate.The customer reported that no injuries had occurred during the incident.To date, handicare have not received the device back from the customer for evaluation.

• Brand Name: B/LIFT HANDSET 5 RETRO US
• Type of Device: BATHLIFT HAND CONTROL
• Manufacturer (Section D): HANDICARE; 82 first ave.; the pensnett estate; kingswinford, west midlands DY6 7FJ; UK DY6 7FJ
• Manufacturer (Section G): RISE LIFTS, INC.; 344 north reading rd.; ephrata PA 17522
• Manufacturer Contact: 344 north reading rd.; ephrata, PA 17522
• MDR Report Key: 3736728
• MDR Text Key: 16594008
• Report Number: 3005536958-2014-00003
• Device Sequence Number: 1
• Product Code: FNG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2014

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
• Device Model Number: 311
• Device Catalogue Number: BP-300-500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/01/2014
• Distributor Facility Aware Date: 03/18/2014
• Device Age: 6 MO
• Event Location: Home
• Date Report to Manufacturer: 04/01/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1