MAUDE Adverse Event Report: LIKO AB LIKOGUARD L; LIFT, PATIENT, NON-AC-POWERED

Model Number 3301030

Device Problem Insufficient Information (3190)

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

Event Date 11/06/2023

Event Type  malfunction  

Manufacturer Narrative

The likoguard overhead lift is part of a liko overhead lift system and is intended for use in following environments, health care, intensive care, emergency ward, rehabilitation, habilitation and home healthcare environment.An overhead lift system can be used for lifting between a bed and a wheelchair and for toileting, lifting to / from the floor, lifting together with a stretcher and rehabilitation training such as walking and standing.The lift was replaced for the customer to resolve the reported issue and the device was requested to be returned to the manufacturer for inspection.The investigation into the reported malfunction is on going.Investigation findings will be submitted in a supplemental report.

Event Description

Hillrom received medwatch report # mw5148453 reporting the following event: "while performing preventative maintenance on a ceiling patient lift, we found a possible manufacturing defect where the mounting point from the motor to the rail became sheared on one side, which caused the device to fall from the ceiling once under load." this incident has been captured under hillrom complaint ref(b)(4).

Event Description

Hillrom received medwatch report # mw5148453 reporting the following event: "while performing preventative maintenance on a ceiling patient lift, we found a possible manufacturing defect where the mounting point from the motor to the rail became sheared on one side, which may cause the device to fall from the ceiling once under load." this incident has been captured under hillrom complaint ref # (b)(4).

Manufacturer Narrative

The unit was returned to the manufacturer for technical analysis.It was determined that an installation error caused a crack in the bracket on the lift.It was determined that the torque of the mounting screws between the lift and the carriage was too high.The direction the bracket was bent in, was in the opposite direction from what could be explained by normal use of the lift and was therefore determined to be caused by a too high mounting torque on the mounting screws during installation.The technical analysis load tested the lift and concluded that it still holds the load it is specified for.This issue would not impact the functionality of the device and the end user would still be able to operate the lift and complete the transfer or return the patient to the previous surface.Therefore, for the reasons listed above, hillrom does not consider this to be a reportable malfunction.

• Brand Name: LIKOGUARD L
• Type of Device: LIFT, PATIENT, NON-AC-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: 18520535
• MDR Text Key: 333540441
• Report Number: 8030916-2024-00002
• 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: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 3301030
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: No
• 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