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

Catalog Number MDR107003E

Device Problems Fire (1245); Temperature Problem (3022)

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

Event Date 08/30/2023

Event Type  Injury  

Event Description

According to the facility the user called stating "the hand control was smoking and had flames coming from it".

Manufacturer Narrative

According to the facility the user called stating "the hand control was smoking and had flames coming from it".Per the user "the location was on the back side of the hand control".Per the facility the user was not injured or hurt when the reported event occurred.The bed was provided by home health wares on (b)(6) 2023.No additional information is available at this time.The sample was requested 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.

• 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: 17756795
• MDR Text Key: 323518257
• Report Number: 1417592-2023-00376
• 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,Followup
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDR107003E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other