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

Model Number MDR107003E

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 03/11/2023

Event Type  malfunction  

Event Description

Bed was sparking.

Manufacturer Narrative

According to the customer on (b)(6) 2023, the "bed plug damaged" and this caused the "plug area where prong was" to have a "burned area".The customer reports "sparking".No injury or medical intervention was reported related to the event.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 is a reportable event.If additional information becomes available this report will be reopened and reevaluated.

• Brand Name: Medline
• Type of Device: BED, BASIC, FULL ELECTRIC
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16753783
• MDR Text Key: 313435643
• Report Number: 1417592-2023-00168
• 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: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: MDR107003E
• Device Catalogue Number: MDR107003E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2023
• 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
• Patient Outcome(s): Other