MAUDE Adverse Event Report: GENDRON GENDROM MAXIREST BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number GENDROM MAXIREST BED

Device Problems Smoking (1585); Sparking (2595); Material Protrusion/Extrusion (2979)

Patient Problem Insufficient Information (4580)

Event Date 12/15/2019

Event Type  malfunction  

Event Description

Per (b)(6), there was a puddle of urine or water on the floor, the cable for the bed was in the puddle.There was a part of the cable exposed and was taped up.She is not certain if it was delivered in the condition or if it was taped up by somebody.The patient's daughter was in the room with her at the time and they heard a spark go off and then it started smoking so they quickly unplugged the cable and called for the nurse.There were other family members there as well but unfortunately, caller does not know their names.Per (b)(6), there was no bodily harm to the patient or anybody else, and there was no property damage, they just smelled the smoke and saw the spark from the cable and the patient's mattress is now deflating.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: GENDROM MAXIREST BED
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): GENDRON
• MDR Report Key: 17535101
• MDR Text Key: 321521257
• Report Number: MW5142000
• Device Sequence Number: 1
• Product Code: FNL
• 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: 12/23/2019

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: GENDROM MAXIREST BED
• Device Lot Number: 4748D
• Patient Sequence Number: 1