MAUDE Adverse Event Report: LINET SPOL. S.R.O. LINET MULTICARE HOSPITAL BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Device Problems Melted (1385); Smoking (1585)

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

Event Date 01/19/2021

Event Type  malfunction  

Event Description

The patient was sitting in her bed.Smoke started to appear due to a transformer melt down which is part of the linet bed.Patient was not harmed by the event.

• Brand Name: LINET MULTICARE HOSPITAL BED
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): LINET SPOL. S.R.O.
• MDR Report Key: 11243487
• MDR Text Key: 229823009
• Report Number: MW5099054
• Device Sequence Number: 1
• Product Code: FNL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 71