MAUDE Adverse Event Report: LIKO AB UNO 102 EE; LIFT, PATIENT, NON-AC-POWERED

Model Number 2010004

Device Problem Sparking (2595)

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

Event Date 11/22/2021

Event Type  malfunction  

Manufacturer Narrative

The damaged power cable had already been replaced.The power cable has not been able to be investigated.The customer has provided a picture of the damaged power cable.The picture shows a damaged and burnt cable.The damage appears on the cable close to one of the cables plug.The damage is likely due to that the cable has been bent and pulled to many times that has caused a short circuit.The electrical parts of hillrom lifts are compliant with (b)(4) (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 for use for uno 102 lifts (7en150104 rev.8) 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.Although the reported event did not result in a serious injury, the report of a charging cable giving a boom noise and a light flame 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 when charging the battery, a boom noise was heard and a light flame occurred.The protective cover on the extension cable had cracked resulting in a short circuit.The lift was located at the account at the time of the incident.There was no patient/user injury reported.This report was filed in our complaint handling system as (b)(4).

• Brand Name: UNO 102 EE
• 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: 14462168
• MDR Text Key: 300344387
• Report Number: 8030916-2022-00026
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2010004
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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