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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2023

Event Type  malfunction  

Manufacturer Narrative

According to the customer on (b)(6) 2023 she was attempting to use her 'remote' for her bed when she 'saw sparks from the remote when being used.' per the customer she immediately stopped using the pendant and did not incur a serious injury or require medical intervention related to the spark.Per the customer the wiring on the pendant is exposed and was identified as the area of the spark.Per the customer the pendant has not been dropped or exposed to liquids, and only has normal wear and tear.The device was purchased from medline in (b)(6) 2022.The sample has not been returned for evaluation.No additional information is available at this time.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

According to the customer on (b)(6) 2023 she was attempting to use her 'remote' for her bed when she 'saw sparks from the remote when being used.'.

• 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: 16219061
• MDR Text Key: 307902637
• Report Number: 1417592-2023-00032
• 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: 01/20/2023

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: 01/06/2023
• Initial Date FDA Received: 01/20/2023
• 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