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

Model Number MDR107002E

Device Problems Overheating of Device (1437); Smoking (1585)

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

Event Date 12/14/2021

Event Type  malfunction  

Event Description

It was reported by the customer to the facility technician that the pendent on his bed started to smoke while on his side rail.The device felt hot and the back of the pendent appeared to be melted.No injuries were reported.

Manufacturer Narrative

It was reported by the customer to the facility technician that the pendent on his bed started to smoke while on his side rail.The device felt hot and the back of the pendent appeared to be melted.No injuries were reported.Per the customer they disconnected the pendent and removed it from his home.The technician retrieved the pendent and determined that there was no fluid ingress or substance noted on the pendent, the pendent was dry.No serious injuries or medical intervention was required.The sample was returned for evaluation and the customer reported issue was confirmed.The sample was confirmed to have a melted area on the back and functional testing was performed and the pendant did not work.A definitive root cause could not be determined at this time.Due to the reported incident 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.

• Brand Name: Medline
• Type of Device: BED,BASIC, SEMI 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: 13656240
• MDR Text Key: 289187771
• Report Number: 1417592-2022-00027
• 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: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MDR107002E
• Device Catalogue Number: MDR107002E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 03/02/2022
• 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 Age: 87 YR
• Patient Sex: Male
• Patient Weight: 61 KG