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

Device Problems Bent (1059); Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 08/16/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation performed by handicare ab shows that the risk for personal damage caused by wrong assembly of leg struts is very low.If exposed to severe use, the leg struts may fracture at most, which would cause the mobile lift to come to a halt in its movement.If a patient is attached to the mobile lift at this time, he/she would also stop moving while staying attached to the mobile lift.The patient could thereafter be safely removed from the mobile lift by healthcare professionals operating the mobile lift.The root cause of the device defect is that the supplier had not properly followed handicare ab's instructions and specifications during device assembly.All affected devices are to be identified.The local distributors will request the affected customers to inspect and to correct the affected devices as according to instructions provided by handicare ab.Necessary spare parts will be provided to the customers as well.

Event Description

The device defect was detected by a local distributor in (b)(4).It was discovered that the right leg strut had switched position with the left leg strut, during assembly on manufacturing stage, on two eva mobile lifts.As the right leg strut and the left leg strut have different lengths, the wrong assembly may impair the function of the mobile lift.The wrongly assembled struts started bending during the event.No patient was injured during this event.

• Brand Name: EVAEE LIFTS
• 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: 5973292
• MDR Text Key: 55469417
• Report Number: 3009481053-2016-00008
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Health Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 09/23/2016

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2016
• Initial Date FDA Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: No
• 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