MAUDE Adverse Event Report: MEDCARE PRODUCTS, INC. MEDCARE LIFT N'WEIGH; MEDCARE LIFT W/SCALE

Model Number 400003

Device Problems Solder Joint Fracture (2324); Device Operates Differently Than Expected (2913)

Patient Problem Fall (1848)

Event Date 01/09/2014

Event Type  malfunction  

Event Description

Patient was being transferred when the metal weld securing the boom to the mast gave way, causing the resident to fall approximately 14" to the ground.The resident showed no signs of injury after an emergency room visit.The lift has been pulled out of service and is going to be replaced.The lift is 14 years old.

• Brand Name: MEDCARE LIFT N'WEIGH
• Type of Device: MEDCARE LIFT W/SCALE
• Manufacturer (Section D): MEDCARE PRODUCTS, INC.; burnsville MN
• Manufacturer Contact: kara lyle ; 87 sharer rd.; vaughan, on L4L 8-Z3 ; CA L4L 8Z3 ; 8509003X2
• MDR Report Key: 3694834
• MDR Text Key: 4292312
• Report Number: 2135150-2014-00001
• 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: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 400003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/1999
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization