MAUDE Adverse Event Report: VANCARE, INC. VANDER-LIFT 450; MECHANICAL PATIENT LIFT

Model Number 450

Device Problem Fail-Safe Problem (2936)

Patient Problems Death (1802); Fall (1848); Head Injury (1879)

Event Date 11/11/2015

Event Type  Death  

Event Description

As described by two na's that were transferring resident with vander-lift 450, they had placed the resident in the sling with straps crossed between legs and attached to the lift according to manufacturer's instructions.When turning the resident to place her in the wheelchair, the resident fell to the floor from the sling and hit her head on the leg of the lift.Following our investigation we learned that there was no deviation from the resident's care plan, there was no deviation from the manufacturer's instructions regarding the use of the lift, there does not seem to be a defect with the equipment.Dates of use: (b)(6) 2010 - (b)(6) 2015.Diagnosis: careplan indicated use of total mechanical lift for transfer.

• Brand Name: VANDER-LIFT 450
• Type of Device: MECHANICAL PATIENT LIFT
• Manufacturer (Section D): VANCARE, INC.; aurora NC 68818
• MDR Report Key: 5243513
• MDR Text Key: 31974237
• Report Number: MW5058028
• Device Sequence Number: 1
• Product Code: FSA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 450
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 95 YR
• Patient Weight: 67