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

Catalog Number MDR107003E

Device Problem Sparking (2595)

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

Event Date 08/14/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported by the customer that the "motor is sparking", this occurred during use.Due to this, the bed has been unplugged and is not being used plugged in.The device was purchased in january.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.

Event Description

"motor is sparking".

• Type of Device: BED, BASIC, FULL ELECTRIC
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield, il 60093 ; MX 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17711963
• MDR Text Key: 322975856
• Report Number: 1417592-2023-00370
• 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: 09/08/2023

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 Catalogue Number: MDR107003E
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/14/2023
• Initial Date FDA Received: 09/08/2023
• 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