MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; DBD-LIFT,PATIENT,ELECTRIC,BARIATRIC,600L

Catalog Number MDS600EL

Device Problem Defective Component (2292)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

Email received by business office manager, alden town manor, with additional information related to a reported incident that, "a nurse was slightly burnt due to a faulty power cord." reporter states, a (b)(6) female nurse had burned her index finger and thumb while trying to plug-in the power cord of the bariatric patient electric lift.Reporter states, there was also "burning smell, spark and the power outlet melted." reporter states, there was no known fluid egress to the electrical component at the time.Reporter states, the nurse (end user) did go to the local emergency room (loyola macneal hospital) that day (11/23/2020) was treated and released that same day.Reporter states, end user prescribed norco and hydrocodone/acetaminophen along with over-the-counter bacitracin, ibuprofen and given one week-off work.Follow-up appointment scheduled 11/30/2020 with dr.Kang, union medical.Reporter states, "the nurse is back to work now and she is doing fine." no further information is available.Due to the reported incident, medical intervention and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported, "a nurse was slightly burnt due to a faulty power cord.".

• Type of Device: DBD-LIFT,PATIENT,ELECTRIC,BARIATRIC,600L
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer (Section G): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: teresa maynard ; three lakes dr; northfield, IL 60093 ; 2249311514
• MDR Report Key: 11028264
• MDR Text Key: 223618747
• Report Number: 1417592-2020-00151
• 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,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MDS600EL
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR
• Patient Weight: 68