MAUDE Adverse Event Report: LIKO AB LIKORALL 250 S, NATURAL, IRC; NON-AC POWERED PATIENT LIFT

Model Number 3124050

Device Problem Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/07/2017

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician is unable to get to the lift system at this time because the account has a patient in the room.The account will notify hill-rom when the lift is available to be inspected and repaired.A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this lift.It is unknown if the facility performs preventative maintenance on their lifts.No further information is available on the repair of the lift at this time.The investigation is ongoing, however if any relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.

Event Description

Hill-rom received a report from the account stating that when the lift goes down the rail, it has sparks coming from the rail charging system.The lift was located in (b)(6) at the account at the time of the allegation.There was no patient/user injury reported.This report was filed in our complaint handling system as (b)(4).

Manufacturer Narrative

The technician was unable to duplicate the issue.The technician made several attempts to further analyze the lift, but it was always in use.The account told the technician they will contact hill-rom when they want hill-rom to service the lift.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating that when the lift goes down the rail, it has sparks coming from the rail charging system.The lift was located in room 5101 at the account at the time of the allegation.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: LIKORALL 250 S, NATURAL, IRC
• Type of Device: NON-AC POWERED PATIENT LIFT
• Manufacturer (Section D): LIKO AB; nedre vägen 100; luleå, norrbottens län [se-25] 975 9 2; SW 975 92
• Manufacturer Contact: marlene bjurman ; nedre vägen 100; luleå, norrbottens län [se-25] 975 9-2 ; SW 975 92
• MDR Report Key: 6383672
• MDR Text Key: 69572121
• Report Number: 8030916-2017-00006
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/07/2017

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 Operator: Other
• Device Model Number: 3124050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2017
• Initial Date FDA Received: 03/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1