MAUDE Adverse Event Report: LIKO AB GOLVO 8008; LIFT, PATIENT, NON-AC-POWERED

Model Number 2000035

Device Problem Naturally Worn (2988)

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

Event Date 09/15/2022

Event Type  malfunction  

Manufacturer Narrative

An onsite inspection of the lift and its components was completed by a hillrom technician.It has been found that the leg widening has detached.It was found that the gear racks were very worn, which made the left fork come out.The worn gear racks led to the left leg unhooking, as the leg widening motor¿s gear was freewheeling.The gear racks are articulation parts and therefore subject to wear and tear.These parts must be checked during preventive maintenance, as their wear depend on the frequency of use.The periodic inspection protocol for liko mobile lifts 3en371001 rev 5 (which describes yearly inspections of liko mobile lifts) states under section 4: inspect the base widening mechanism, open and close the base to maximum and minimum positions, make a functional check of the base widening, make sure all screws and nuts are tightened.The instruction guide for golvo 8008, 7en140107 rev 3, states under care and maintenance; for trouble-free use, certain details should be checked each day the lift is used: inspect the lift and check to make sure that there is no external damage.Check the integrity of the lifting motion and the base-width adjustment.The ifu further states: a periodic inspection of the lift should be carried out at least once per year.Although there was no patient injury associated with the reported event, the report of the mobile lift leg detaching during patient transfer, could contribute to a serious injury or death, if the malfunction were to recur.Therefore, hillrom considers this complaint a reportable malfunction.

Event Description

The customer reported that during a maneuver with the patient lift, one of the forks (left) became detached from the patient lift.The carer reported: we had installed the resident in the net to lift her after her toilet, suspended in the net in the room outside the bed, we were going to install her in the chair located in the corridor, halfway the left foot of the patient lift came off in one go.The lift was only holding on to the right leg of the unit.We then very quickly moved the bed closer to the resident to put her back in it.There was no patient/user injury reported.This report was filed in our complaint handling system as c-(b)(4).

• Brand Name: GOLVO 8008
• 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: antonio acquafredda ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 15518187
• MDR Text Key: 305829281
• Report Number: 8030916-2022-00048
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2000035
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2022
• 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