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

Model Number	2000045
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The electrical parts of hillrom lifts are compliant with iec 60601-1 medical electrical equipment - part 1: general requirements for basic safety and essential performance which applies to the basic safety and essential performance of medical electric equipment and medical electric systems.Even though all hillrom lifts comply to the above mentioned electrical standard, there is still a risk that abnormal wear and tear can damage the cables.Therefore, hillrom states in the periodic inspection manual for liko mobile lifts 3en371001 rev.5 under section 8: verify that all cables are properly inserted.Re-insert if uncertain.Verify battery charge by inspecting the charger indicator.Check cables and connectors for damage or wear.In the instruction manual for golvo 9000 lifts 7en140108 rev.5 states, under inspection and maintenance section: a periodic inspection of the lift should be carried out at least once per year.Periodic inspection, repair and maintenance may be performed only in accordance with the liko service manual by personnel authorized by hillrom and using original liko spare parts.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.If the instruction as outlined above are followed it is unlikely for an injury to occur due to this error.The charging cable and power supply box will be replaced to resolve the issue.In conclusion, although the reported event did not result in a patient injury, the report of a charging cable burning could contribute to a serious injury or death, if the malfunction were to recur.Therefore, hillrom considers this complaint a reportable malfunction.
Event or Problem Description
The customer alleged the lift was experiencing a short-circuit problem and caused the power cable connector to burn.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: 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: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 19357600
• Report Number: 8030916-2024-00024
• Device Sequence Number: 3728149
• Product Code: FSA
• UDI-Device Identifier: 00887761981737
• UDI-Public: 010088776198173711211223
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 05/03/2024
• Initial Report FDA Received Date: 05/21/2024
• 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
• Patient Sex: Unknown