MAUDE Adverse Event Report: BEDS BY GEORGE BED BY GEORGE DREAM SERIES FULL SIZE HIGH-SIDE SAFETY BED WITH CANOPY; BED MANUAL

Model Number 2700

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Physical Entrapment (2327)

Event Date 04/12/2019

Event Type  Injury  

Event Description

Consumer was placed in her beds by george full sized dream series 2700 safety bed for sleep as usual.She had been sleeping in the new bed since it was delivered mid (b)(6) 2019.About 0530 in the morning, mom heard a repetitive sound like someone was kicking a door.Went to investigate where it was coming from.Ended up across the hall in (b)(6) room.Looked in her safety bed and she was not visible.Upon closer inspection, the mattress appeared elevated.The kicking sound was still being heard.Mom released the side rail and found (b)(6) awake and underneath the mattress.(b)(6) climbed out with assistance.No visible injuries.She was fully awake and conscious.Notified beds by george employee (b)(6).(b)(6) requested bed measurements and extensive photographs.He refused to send a beds by george employee in person to look at the bed when parents requested it.He determined solely from photographs that the mattress was too small for the bed frame and needed to be medical grade foam not innerspring.(b)(6) stated that a new custom-sized (larger) medical-grade foam mattress would be sent to consumer's home asap and within the week.Two weeks have passed and no replacement mattress received to date.Entrapment of consumer.Fda safety report id# (b)(4).

• Brand Name: BED BY GEORGE DREAM SERIES FULL SIZE HIGH-SIDE SAFETY BED WITH CANOPY
• Type of Device: BED MANUAL
• Manufacturer (Section D): BEDS BY GEORGE
• MDR Report Key: 8569260
• MDR Text Key: 143937925
• Report Number: MW5086300
• Device Sequence Number: 1
• Product Code: FNJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2700
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 17 YR
• Patient Weight: 60