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

Model Number 2020003

Device Problem Material Integrity Problem (2978)

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

Event Date 03/20/2023

Event Type  malfunction  

Event Description

The customer alleged the lift¿s emergency stop button needed to be replaced.There was no allegation of patient or caregiver injury, or death reported from this alleged incident.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The control box was replaced to resolve the reported issue.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.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.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
• 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: 16767171
• MDR Text Key: 313668908
• Report Number: 8030916-2023-00032
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• 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
• Date Manufacturer Received: 03/20/2023
• 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