MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; 2 PCS BED, LOW FULL ELECTRIC, MEDLITE

Model Number MDR107003LO

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 03/03/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer, the cord on the bed was "rolled over or pinched" and there was a visualized "spark." the customer reported there were no injuries or medical intervention that occurred related to the reported incident.Sample was requested for return 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 again.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, the cord on the bed was "rolled over or pinched" and there was a visualized "spark.".

Manufacturer Narrative

Updated h6: type of investigation and investigation conclusion.

• Brand Name: MEDLINE
• Type of Device: 2 PCS BED, LOW FULL ELECTRIC, MEDLITE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16583945
• MDR Text Key: 311690195
• Report Number: 1417592-2023-00125
• Device Sequence Number: 1
• Product Code: LLI
• UDI-Device Identifier: 40080196325901
• UDI-Public: 40080196325901
• 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,Followup
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: MDR107003LO
• Device Catalogue Number: MDR107003LO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2023
• 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