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

Model Number GENDRON BED

Device Problem Insufficient Information (3190)

Patient Problem Fall (1848)

Event Date 04/30/2019

Event Type  Injury  

Event Description

Per facility employee, patient scooted off of the mattress and was found sitting on the floor on her bottom and laughing.The patient did not sustain any injuries.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BED, AC-POWERED ADJUSTABLE HOSPTIAL
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): GENDRON
• MDR Report Key: 17525732
• MDR Text Key: 321099226
• Report Number: MW5132673
• 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: 05/21/2019

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: GENDRON BED
• Device Lot Number: MC4748SD
• Patient Sequence Number: 1