MAUDE Adverse Event Report: VANCARE VANDER LIFT II; MECHANICAL LIFT

Model Number B450

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 01/07/2016

Event Type  Death  

Event Description

Employee improperly applied sling to vander lift mechanical lift resulting in resident falling hitting head and dying of complications from head injury on (b)(6) 2016.On (b)(6) 2016 3 nursing assistants were assisting a resident from bath chair to wheel chair when in the process of attaching the sling to the mechanical lift the nursing assistant did not apply the loops on the sling to the lift appropriately and began to lift the resident the sling became unhooked the resident fell and hit her head.She died from complication of her head injuries on (b)(6) 2016.(b)(6).

• Brand Name: VANDER LIFT II
• Type of Device: MECHANICAL LIFT
• Manufacturer (Section D): VANCARE; aurora NE 68818
• MDR Report Key: 5396703
• MDR Text Key: 37083693
• Report Number: MW5059710
• Device Sequence Number: 1
• Product Code: FNG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: B450
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death