MAUDE Adverse Event Report: GENDRON BED, MANUAL

Model Number 4748D

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Insufficient Information (4580)

Event Date 06/26/2013

Event Type  malfunction  

Event Description

Patient pushed call bell, staff member entered patient room, smelled smoke, the staff member saw smoke coming from the bed plug in the wall.Staff member pulled fire alarm, evacuated patient from room because of the smoke.Patient is in another rrom.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BED, MANUAL
• Type of Device: BED, MANUAL
• Manufacturer (Section D): GENDRON
• MDR Report Key: 17529903
• MDR Text Key: 321344860
• Report Number: MW5136826
• Device Sequence Number: 1
• Product Code: FNJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 4748D
• Patient Sequence Number: 1
• Patient Age: 65 YR