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

Model Number 2020003

Device Problem Defective Component (2292)

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

Event Date 02/08/2023

Event Type  malfunction  

Event Description

The customer reported the lift needs pm service.It was stated that the lift's emergency stop button was not functioning normally.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

During follow-up the customer stated the facility has a covid-19 outbreak, therefore, a site visit cannot be scheduled at this time.Customer will call to reschedule the service.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.According to hillrom¿s periodic inspection for liko mobile lifts (3en371001 rev.4), the emergency stop function must be checked at least once every year.In the document it is stated under section 10: press the emergency stop button.With the emergency stop pressed in, verify the lift does not operate with the hand control buttons; turn the red emergency button in the direction of the arrows.Verify the button releases from the locked position into the raised, open position.A search was performed of hillrom pm records, and it showed that the last pm date was (b)(6) 2018.Hillrom is not aware if the customer performs their own pm.A site visit cannot be scheduled at this time; therefore a route cause could not be identified.Customer will call to reschedule the service.If any relevant information will be identified following completion of the investigation, a follow-up report will be submitted.Based on this, no further action is required at the moment.Although the reported event did not result in a serious injury and a route cause could not be identified, the report of an emergency button not functioning 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.

• Brand Name: SABINA II 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: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 16495075
• MDR Text Key: 310796514
• Report Number: 8030916-2023-00017
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2020003
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: No
• 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