MAUDE Adverse Event Report: LIKO AB SABINA II EM; LIFT, PATIENT, NON-AC-POWERED

Model Number SABINA2EM

Device Problem Sparking (2595)

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

Event Date 07/13/2023

Event Type  malfunction  

Manufacturer Narrative

The hrc technician replaced the control box and network cable to resolve the issue.The sabina sit-to-stand lift is especially designed for people who have difficulty in standing up on their own from a seated position.Sabina sit-to-stand lift is intended for use with patients who are able to actively participate in the raising motion.When standing, they can be moved to a wheelchair or to a toilet, this gives them standing practice in connection with the transfer.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 as 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) it is stated 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 sabina ii sit to stand lifts (7en155106 rev.2) it is stated on page 4: "before lifting, always make sure that: the lifting accessories are not damaged" if the instruction as outlined above are followed it is very 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 sparking control box 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 hrc service technician found the connection with the box was bad and made sparks.There was no allegation of patient or caregiver injury or death reported from this alleged incident.This incident was captured under hillrom complaint ref # (b)(4).

• Brand Name: SABINA II EM
• 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: 17508644
• MDR Text Key: 320867704
• Report Number: 8030916-2023-00056
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SABINA2EM
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2023
• 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