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

Model Number GENDRON BED

Device Problem Device Fell (4014)

Patient Problem Fall (1848)

Event Date 04/10/2019

Event Type  Injury  

Event Description

A screw had fallen out of the headboard so that when the patient put pressure on the headboard to help him get out of the bed he fell.There are no injuries reported.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MAXIREST
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): GENDRON
• MDR Report Key: 17531049
• MDR Text Key: 321052192
• Report Number: MW5137965
• 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: 04/19/2019

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: MAXIREST
• Patient Sequence Number: 1