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

Model Number	2020003
Medical Device Problem Code	Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Hillrom received a report from the account that the emergency stop on the sabina ii ee sit to stand lift is not working.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #: (b)(4).
Additional Manufacturer Narrative
The hillrom technician found that the control box needed to be replaced.The sabina lift should be subject to periodic inspection at least once per year according to the ifu, 7en155106 rev.2.A search of the hillrom maintenance records, resulted in no preventative maintenance record on this lift.It is unknown if the account performed any preventative maintenance on this lift.The periodic inspection for mobile lifts and sit-to-stand lifts (3en371001, rev 5) states: 10 emergency stop press the emergency stop button.With the emergency stop pressed in, verify that the hand control buttons do not operate the lift.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 new control box including a new emergency stop has been sent to the account for replacement to resolve the issue.Based on this information, no further action is required.

• Brand Name: SABINA II EE
• Common Device Name: NON-AC POWERED PATIENT LIFT
• Manufacturer (Section D): LIKO AB; nedre vagen 100; lulea, norrbottens lan [se-25] 975 9 2; SW 975 92
• Manufacturer Contact: kayla miller ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 13357821
• Report Number: 8030916-2022-00006
• Device Sequence Number: 12007986
• Product Code: FSA
• UDI-Device Identifier: 00887761981782
• UDI-Public: 010088776198178211210802
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/26/2022

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: 2020003
• 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: 01/06/2022
• Initial Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2021
• 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