MAUDE Adverse Event Report: TOLLOS, INC. TOLLOS; MOBILE LIFT

Model Number	ULTRALIFT 600
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Fall (1848); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer/facility reported that the lifting actuator (linak) on an ultralift broke while lifting a patient.The patient was not injured.Of note is that the lift dom was (b)(6) 2012 and the actuator is original to the lift.Please note that the facility would not provide any patient related data, so the information listed is only a placeholder so that this report could be submitted.
Additional Manufacturer Narrative
Tollos does not have enough information to determine the failure mode, but based upon age, it is believed that the most likely cause is simply weakening with years of wear and tear.This conclusion is based mostly on the rarity of an actuator failure.Tollos has never received a report of a linak actuator failure in the years that they have been used.

• Brand Name: TOLLOS
• Common Device Name: MOBILE LIFT
• Manufacturer (Section D): TOLLOS, INC.; 8 easter court; owings mills MD 21117
• Manufacturer (Section G): TOLLOS MANUFACTURING; 75 dyment road; barrie, ontario L4N 3 H6; CA L4N 3H6
• Manufacturer Contact: darrell hinger ; 8 easter court; owings mills, MD 21117 ; 8883637224
• MDR Report Key: 18243020
• Report Number: 3008406502-2023-00005
• Device Sequence Number: 20630819
• Product Code: FSA
• UDI-Device Identifier: 00817956020026
• UDI-Public: 817956020026
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 11/30/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: ULTRALIFT 600
• Device Catalogue Number: TUL-600-LA-LG-L03-LM
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 91 KG