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

Model Number MDR107003E

Device Problems Mechanical Problem (1384); Temperature Problem (3022)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/20/2023

Event Type  Injury  

Event Description

According to the facility "the client reported a burning smell and witnessed the remote with sparks and residual smoke and they unplugged it immediately".

Manufacturer Narrative

According to the facility "the client reported a burning smell and witnessed the remote with sparks and residual smoke and they unplugged it immediately".Per the facility there were no injuries reported and the client did not require medical intervention.Sample requested to be returned for evaluation.No additional information is available at this time.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.

• Brand Name: Medline
• Type of Device: BED, BASIC, FULL ELECTRIC
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17315473
• MDR Text Key: 318935418
• Report Number: 1417592-2023-00289
• Device Sequence Number: 1
• Product Code: LLI
• UDI-Device Identifier: 40080196321002
• UDI-Public: 40080196321002
• 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
• Report Date: 07/13/2023

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 Model Number: MDR107003E
• Device Catalogue Number: MDR107003E
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 07/13/2023
• 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): Other