MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; BED,BASIC, SEMI ELECTRIC

Catalog Number MDR107002E

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported by the customer that "the cable on the pendant is damaged.It's the side connected to the pendant.Customer can see the wires.Not sure how this occurred".Additionally, the pendant began "sparking and smoking".No additional details were provided at this time.A sample was requested to be returned for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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

"pendant was sparking and smoking and had a smokey smell.".

Manufacturer Narrative

A sample was returned and evaluated.

• Type of Device: BED,BASIC, SEMI ELECTRIC
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18464634
• MDR Text Key: 332987170
• Report Number: 1417592-2024-00015
• Device Sequence Number: 1
• Product Code: LLI
• UDI-Device Identifier: 40080196320999
• UDI-Public: 40080196320999
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/08/2024

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 Catalogue Number: MDR107002E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other