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

Catalog Number MDR107002E

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Burn(s) (1757)

Event Date 12/04/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer, on (b)(6) 2023 the patient was sleeping in the bed when "the head of bed started rising on its own" and "the bed remote caught on fire".The customer reported there was "smoke", a chemical smell in the air, the mattress was burned, and the patient's thumb was "burnt".The customer reported the patient's thumb had a "blister" and did not require treatment.The customer reported the patient is "doing fine".The customer reported there was no serious injury, medical intervention, or follow up care related to the reported incident.No additional information is available at this time.Sample requested for return evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.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

According to the customer, on (b)(6) 2023 the patient was sleeping in the bed when "the head of bed started rising on its own" and "the bed remote caught on fire".

• Type of Device: BED,BASIC, SEMI ELECTRIC
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18499152
• MDR Text Key: 332723052
• Report Number: 1417592-2024-00024
• 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
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDR107002E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2024
• Date Manufacturer Received: 12/13/2023
• 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