MAUDE Adverse Event Report: MEDCARE FULL BODY FLOOR LIFT ; TOTAL LIFT

Model Number 400003

Device Problem Device Slipped (1584)

Patient Problems Fall (1848); No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2015

Event Type  malfunction  

Event Description

During a transfer using the full body floor lift with a care sling, a stop came loose, ending with the resident being tipped to the left and hitting their head and elbow on the floor and sliding out of the sling.The facility reported usual range of motion and usual level of consciousness noted and indicated no clinic assessment required.

Manufacturer Narrative

The facility indicated, "upon investigation noted the black stopper on the lift was not in the correct placement to hold sling into place.Stopper was repositioned correctly".Also, the facility pointed out, "maintenance does inspect lifts monthly and replaces stoppers.Last inspection was completed 05/15/2015.Nothing unusual noted upon inspection.Maintenance will continue to inspect lifts regularly and cna's educated to monitor stopper positioning closely when using lifts".Medcare representative visited the facility and reported, "nothing wrong with lift".Root cause: improper use of the sling with the lift, by not verifying the strap was correctly positioned post the rubber stop prior to lifting the pt.(b)(4).

Manufacturer Narrative

Patient code need to be updated to show 1848 and code 2692 should be removed.

• Brand Name: FULL BODY FLOOR LIFT
• Type of Device: TOTAL LIFT
• Manufacturer (Section D): MEDCARE ; burnsville MN 55337
• Manufacturer Contact: steve kilburn ; 3142198614
• MDR Report Key: 4929459
• MDR Text Key: 6434636
• Report Number: 3007802293-2015-00024
• 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: Health Professional,User Facility,Company Representative,Distributor,company represent
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 400003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2015
• 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
• Patient Age: 86 YR
• Patient Weight: 76