MAUDE Adverse Event Report: LIKO AB GOLVO 9000; LIFT, PATIENT, NON-AC-POWERED

Model Number	2000045
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	04/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that during the use of the golvo lift, the lift's caster wouldn't roll, as the caregiver was attempting to maneuver the lift over the threshold, the patient fell and sustained a broken hip.During a follow-up call with the customer, the customer stated that the lift /patient was being moved from a carpeted area, "causing resistance" over a threshold in the doorway to a vinyl floored area and that three of the lifts casters were not rolling, causing more resistance.The caregiver then "gave the lift a big yank" causing the patient to fall.The customer also contributes the event to "operator error" and stated that the yank likely made the sling and patient swing, along with the loosening of the bunched-up lift strap, and this caused the patient to fall.A hillrom service technician has inspected the lift and noted the lift's right head caster hard to roll or spin its wheel.The lift strap to be frayed, wrinkled, and very worn.It is also noted that the sling bar was missing one of its latches.Further it was found that one hook on the slingbar had broken.Follow-up with the customer determined that the breakage of one end of the slingbar occurred after and was unrelated to the event.According to the instruction for use for golvo 9000 mobile lifts (7en140108, rev.1) certain environments and conditions can limit the correct use of the mobile lifts, including: thresholds, unlevel floor surfaces, various obstacles, and extra-thick carpets.These environments and conditions can cause the wheels of the mobile lift not to roll as intended, possible imbalance in the mobile lift, and increased exertion by the caregiver.Before lifting, always make sure that: the latches are intact.Missing or damaged latches must always be replaced with new ones; the sling¿s strap loops are correctly connected to the sling bar hooks when the sling strap is extended but before the patient is lifted from the underlying surface.Based on the details provided, the event is likely due to misuse of the user causing a swinging motion of the sling/patient by "yanking" on the device together with a misapplication of the slings loop on the slingbar hook.Although details regarding the treatment for the patient's broken hip were not provided, surgery is almost always required for severe fractures and therefore meets the definition of a serious injury.Thus, hillrom considers this a reportable event.
Event or Problem Description
The customer reported that one of the locking casters would not roll and the customer pulled on the lift to get the caster to roll, and when doing this the patient fell out of the sling and broke their hip.This report was filed in our complaint handling system as (b)(4).

• Brand Name: GOLVO 9000
• Common Device Name: 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: 14494733
• Report Number: 8030916-2022-00028
• Device Sequence Number: 17647092
• Product Code: FSA
• UDI-Device Identifier: 00887761981737
• UDI-Public: 010088776198173711170601
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/25/2022

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?: No
• Device Model Number: 2000045
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown