BED BY GEORGE DREAM SERIES FULL SIZE HIGH-SIDE SAFETY BED WITH CANOPY 2700

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-30 for BED BY GEORGE DREAM SERIES FULL SIZE HIGH-SIDE SAFETY BED WITH CANOPY 2700 manufactured by Beds By George.

Event Text Entries

[143937925] 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).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5086300
• MDR Report Key: 8569260
• Date Received: 2019-04-30
• Date of Report: 2019-04-26
• Date of Event: 2019-04-12
• Date Added to Maude: 2019-05-01
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: BED BY GEORGE DREAM SERIES FULL SIZE HIGH-SIDE SAFETY BED WITH CANOPY
• Generic Name: BED MANUAL
• Product Code: FNJ
• Date Received: 2019-04-30
• Model Number: 2700
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BEDS BY GEORGE

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2019-04-30