MAUDE Adverse Event Report: HANDICARE AB MINILIFT200; LIFT, PATIENT, NON AC-POWERED

Device Problems Break (1069); Solder Joint Fracture (2324); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/01/2016

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer yet.It was not possible to collect the device because the client wanted to hold it until workers' compensation claim has been finalized.Initial investigation showed that the device had a broken weld between base bottom and leg post.The client had 6 lifts in total and all lifts have been removed from service by the facility.One more lift had a fault with a broken weld between base bottom and leg post.The facility had attempted to repair it themselves by drilling hole in the leg post.The client was offered 2 new lifts by handicare.No health hazard evaluation (hhe) is attached to this mdr report.Handicare has not been able to investigate this issue further since the affected devices have not been returned to the company.Handicare has therefore concluded that no information of significance can be provided through an hhe at this time.

Event Description

Lift weld broke, lift fell over and hit employee in the back.The employee got a lumbar compression fracture and received medical treatment including ct-scans and pain management.

• Brand Name: MINILIFT200
• Type of Device: LIFT, PATIENT, NON AC-POWERED
• Manufacturer (Section D): HANDICARE AB; handicare ab; maskinvägen 17; luleå, 972 5 4; SW 972 54
• Manufacturer Contact: jonny munter ; handicare ab; maskinvägen 17; luleå, 972 5-4 ; SW 972 54 ; 68 5576220
• MDR Report Key: 5945221
• MDR Text Key: 54527124
• Report Number: 3009481053-2016-00001
• 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: company representative,health
• Reporter Occupation: Nursing Assistant
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/03/2016,06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/03/2016
• Device Age: 7 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/03/2016
• Initial Date Manufacturer Received: 03/03/2016
• Initial Date FDA Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 54 YR
• Patient Weight: 123