MAUDE Adverse Event Report: VITALGO SYSTEMS TOTAL LIFT; BED, AC-POWERED ADJUSTABLE HOSPITAL

Device Problem Positioning Problem (3009)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Arjohuntleigh was informed that on (b)(6) 2018 an (b)(6) employee (clinical consultant wound care and bariatrics) got injured her right shoulder while "manually moving the total lift bed amongst the floors at (b)(6) medical center in (b)(6) in order to educate and in service the clinical staff on the total lift bed (tlb)." per arjohuntleigh clinical consultant: "myself and 2 other colleagues were in-servicing the staff on the total lift bed within the 17 icus and step down units at (b)(6) medical center.The tlb weighs 695 lbs and does not have power assist in order to move it from 011e location to another therefore requiring one to manually push the bed.The tlb also exhibits difficulty with its maneuverability resulting in frequent needed corrections to its path of movement during transporting the bed from unit to unit.I experienced discomfort in my right shoulder during the activity of pushing the total lift bed on (b)(6) 2018 and a worker's injury report was filed.My colleagues both reported soreness in their back after many hours of manually moving the bed in order to in-service from unit to unit." an arjohuntleigh employee indicated that three total lift beds were used for in-service training that day with serial numbers (b)(6).One of the unit was involved in the incident.Please note that arjohuntleigh did not manufacture or import the device in question.The vitalgo manufacturer has been already informed about an incident.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TOTAL LIFT
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): VITALGO SYSTEMS
• MDR Report Key: 17534910
• MDR Text Key: 321150964
• Report Number: MW5141810
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1