MAUDE Adverse Event Report: HANDICARE BATH BLISS RECLINER US AB; 311 BATHLIFT

Model Number 311

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Distress (2329)

Event Date 02/24/2014

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 had 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 was able to get out of the tub with the aid of her husband and no injuries were reported as a result of the incident.To date, handicare have not received the suspect device back for evaluation however, the hand control is currently being recalled.

• Brand Name: BATH BLISS RECLINER US AB
• Type of Device: 311 BATHLIFT
• Manufacturer (Section D): HANDICARE; 82 first ave, the pensnett estate; kingswinford; west midlands, england ; UK
• MDR Report Key: 3815707
• MDR Text Key: 15322571
• Report Number: 3005536958-2014-00008
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2014
• 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: BBR1311USAB
• 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: 05/05/2014
• Distributor Facility Aware Date: 04/11/2014
• Device Age: 18 MO
• Event Location: Home
• Date Report to Manufacturer: 05/05/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 108