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 11/30/2022

Event Type  malfunction  

Manufacturer Narrative

According to the facility contact on (b)(6) 2022 their client was in another room when they noticed a burning smell coming from the room the bed was located in.Per the facility it was noted that the smell was coming from the pendant which had experienced visible 'melting' and is no longer usable.Per the facility there was no injury or medical intervention related to the 'melted pendant' as the bed was not in use at the time of the event.The sample is available to be returned for evaluation.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 facility contact on (b)(6) 2022 their client was in another room when they noticed a burning smell coming from the room the bed was located in.

• 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: 16005933
• MDR Text Key: 306240913
• Report Number: 1417592-2022-00239
• Device Sequence Number: 1
• Product Code: LLI
• 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: 12/19/2022

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: Other
• Device Model Number: MDR107003E
• Device Catalogue Number: MDR107003E
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/19/2022
• 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