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

Model Number MDR107003E

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 11/01/2022

Event Type  malfunction  

Manufacturer Narrative

According to the customer, in early november, he needed to move his mother in law's bed in a memory care facility because she wasn't using it.Customer states 'upon removing the mattress and locating the wall outlet, i immediately noticed that the power cord had a nick in it, i turned the unit on and immediately, a small plum-sized blue spark/flame emerged from the cord'.There was not a person in the bed at this time and no injury was reported.The sample is reported to be available.No additional information is available 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.

Event Description

According to the customer, in early november, he needed to move his mother in law's bed in a memory care facility because she wasn't using it.Customer states 'upon removing the mattress and locating the wall outlet, i immediately noticed that the power cord had a nick in it, i turned the unit on and immediately, a small plum-sized blue spark/flame emerged from the cord'.

• 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: 15924631
• MDR Text Key: 307835712
• Report Number: 1417592-2022-00234
• 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: 12/06/2022

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: MDR107003E
• Device Catalogue Number: MDR107003E
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/15/2022
• Initial Date FDA Received: 12/06/2022
• 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