MAUDE Adverse Event Report: LIKO AB UNO 102 EE; MOBILE PATIENT LIFTING SYSTEM, BATTERY-POWERED

Model Number 2010004

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2023

Event Type  malfunction  

Manufacturer Narrative

Uno 102 mobile lift has electric raising and lowering of the lift arm.Uno mobile lift is intended mainly for use in post acute care facilities like nursing homes and other care homes in the most common lifting situations, for instance, transfers between bed and wheelchair, to and from toilet and for lifting to and from the floor.Uno mobile lift has three alternative height settings, in order always to provide the optimum lifting height.Follow up attempts have been made by hillrom with the customer to obtain additional information regarding the event but no response has been received at this time.Images of the lift were provided by the customer.Upon inspection of the images provided, it was noted that there was a bolt missing from the rear wheel bracket, this is assumed to be the root cause of the reported issue.The hillrom technician evaluated the lift and found that the wheel had unscrewed from the nut.The hole through which the screw passed was worn.This is likely due to the lift continuing to be used while the wheel was loose.No damage to the wheel was found.The nut remained under the cover cap and the locking pin on the cover cap was not damaged.Per the hillrom user manual, the uno 102 ee lift must be inspected at least once per year.According to the periodic inspection (3en371001-rev 5) for mobile lifts, the following shall be checked: castors - wheels roll the lift along the floor.Check to ensure that all wheels roll and turn freely.Make sure the wheels are fastened.Lock the brakes, make sure the wheels do not turn and the housing does not swivel when the lift is pushed.There should not be any play between the fork and the wheel nut.Although there was no injury reported, if the rear wheel were to come loose from the lift it could cause or contribute to a death or serious injury if this were to recur.Therefore hillrom is reporting this malfunction.

Event Description

Hillrom received a user report from the swedish mpa regarding a uno 102 ee lift, with the following customer description of the event: "the customer alleged that one of the wheels came loose from the lift.There was no allegation of patient or caregiver injury or death reported from this alleged incident." this report was filed in our complaint handling system as (b)(4).

• Brand Name: UNO 102 EE
• Type of Device: MOBILE PATIENT LIFTING SYSTEM, BATTERY-POWERED
• Manufacturer (Section D): LIKO AB; nedre vagen 100; lulea, norrbottens lan [se-25] 975 9 2; SW 975 92
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 16984015
• MDR Text Key: 315754931
• Report Number: 8030916-2023-00041
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2010004
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1