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

Catalog Number MDR107003E

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Electric Shock (2554)

Event Date 12/18/2023

Event Type  Injury  

Event Description

According to the customer on 12/18/23 "the bed remote was being used to move the bed forward and bed stopped moving".Per the customer "my nephew was shocked when he touched the wire".

Manufacturer Narrative

According to the customer on 12/18/23 "the bed remote was being used to move the bed forward and bed stopped moving".Per the customer "my nephew was shocked when he touched the wire".There was no note of injury or medical intervention that was required related to the reported incident.No additional information is available.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: 18506930
• MDR Text Key: 332872840
• Report Number: 1417592-2024-00025
• 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: 01/12/2024

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 Operator: Lay User/Patient
• Device Catalogue Number: MDR107003E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2023
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/12/2024
• 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