MAUDE Adverse Event Report: SUNRISE MACHINE AND TOOL, INC. VOLARO HOYER LIFT SERIES 4; LIFT, PATIENT, AC-POWERED

Device Problem Device Tipped Over (2589)

Patient Problems Fall (1848); Hip Fracture (2349)

Event Date 07/20/2022

Event Type  Injury  

Event Description

The volaro hoyer lift series 4 was used to lift the resident.The resident was lifted with the hoyer from the wheel chair to transfer to the bed.Two cnas were assisting the transfer, one operating the lift while the other was supporting and guiding the resident.The feet of the hoyer were spread apart.The entire lift tipped over mid-transfer and the resident hit the floor.The resident sustained a hip fx and was admitted to the hospital for surgery.Fda safety report id# (b)(4).

• Brand Name: VOLARO HOYER LIFT SERIES 4
• Type of Device: LIFT, PATIENT, AC-POWERED
• Manufacturer (Section D): SUNRISE MACHINE AND TOOL, INC.; 1380 legion road; detroit lakes MN 56501
• MDR Report Key: 15113115
• MDR Text Key: 296785453
• Report Number: MW5111132
• 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: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 336 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White