MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. ELECTRIC PATIENT LIFT; CHAIR, POSITIONING, ELECTRIC

Model Number MDS600EL

Device Problems Smoking (1585); Material Deformation (2976); Temperature Problem (3022); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 03/22/2017

Event Type  malfunction  

Event Description

Almost four months ago, electric lift was sitting plugged in when a physician walked by it and heard it "popping and crackling" and smelled smoke.Maintenance was notified and arrived to find the lift was the cause and noted the charger and battery box to be very hot.Lift was unplugged and taken to the clinical engineering department for review.The battery pack and the charger was transported to the clinical engineering shop.When the battery pack was opened, they found "2 batteries very swollen and deformed." new batteries were purchased, installed and unit charged with a new charger for several hours with the battery pack open to assure no smoking occurred.After no issue, the battery pack was reassembled and installed into the lift.The unit ran up and down as expected.Lift continued to charge and tested one final time over night with no issues.Lift returned to service.Clinical engineering reports that a similar situation occurred one month ago on another same model lift, but not as severe.About one month ago, it was reported: "facilities brought unit to us stating they received a call about a bad smell in the storage room." after testing, found that the ac adapter was bad, not the batteries.Tested unit with new ac adapter and unit is working as it should per tech support.Ordered new batteries.Also installed new batteries, tested and was able to return to service.It was reported that the battery casing was slightly warped and the batteries were swollen, but did not explode.Manufacturer response for electric lift: clinical engineering did discuss the previous event with the tech support and the decision was made to change the batteries and the charger.

• Brand Name: ELECTRIC PATIENT LIFT
• Type of Device: CHAIR, POSITIONING, ELECTRIC
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 6471548
• MDR Text Key: 72093289
• Report Number: 6471548
• Device Sequence Number: 1
• Product Code: INO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/22/2017,03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MDS600EL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/22/2017
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1