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

Model Number	2020003
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the unit control box was damaged and looked like the emergency stop button was smashed.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).
Additional Manufacturer Narrative
The sabina lift should be subject to periodic inspection at least once per year according to the device ifu, (7en155106 rev.2).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.The customer replaced the control box to resolve the issue.Based on this information, no further actions are required.Although the reported event did not result in a serious injury, 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
• 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: 17694496
• Report Number: 8030916-2023-00062
• Device Sequence Number: 14981618
• Product Code: FSA
• UDI-Device Identifier: 00887761981782
• UDI-Public: 010088776198178211170711
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/06/2023

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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