MAUDE Adverse Event Report: VANCARE INC. VANDER-LIFT II MECHANICAL LIFT; LIFT, PATIENT, NON-AC-POWERED

Model Number B450

Device Problem Device Slipped (1584)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Head Injury (1879); Hemorrhage, Cerebral (1889); Laceration(s) (1946)

Event Date 04/16/2020

Event Type  Injury  

Event Description

During a transfer from the mechanical lift a strap slacked and looped back over the hook and when weight was applied slipped out of the safety clip which caused the patient to fall to the floor.She was sent to the er and found to have obtained a head injury with a laceration and multiple small cerebral hemorrhages, a fracture of her left hip, and a fracture of her right pelvic bone.She was signed into hospice at the hospital.Fda safety report #: (b)(4).

• Brand Name: VANDER-LIFT II MECHANICAL LIFT
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): VANCARE INC.
• MDR Report Key: 9983019
• MDR Text Key: 188703890
• Report Number: MW5094208
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• 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: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: B450
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 99 YR
• Patient Weight: 75