MAUDE Adverse Event Report: SLEEPSAFE BEDS, LLC SLEEPSAFE BEDS; BED, MANUAL

Model Number S2-ME-CH-T

Device Problem Device Slipped (1584)

Patient Problem Fall (1848)

Event Date 09/15/2019

Event Type  Injury  

Event Description

My (b)(6) year old son has cerebral palsy and is quadriplegic.He also has epilepsy.He cannot sit up, stand, walk, or talk.He has a sleepsafe bed (https://sleepsafebed.Com/wp/wp- content/uploads/2019/ 03/sleepsafe-bed­-specification-low.Pdf) the company information is: phone number: 866-607-0753.The model of the bed is s2- me-ch-t and serial# (b)(4).The date of delivery was 06/22/2018.A sleepsafe employee i spoke with is (b)(4).The company we purchased the bed through was (b)(6).The bed has a side panel that folds up and down so we can put our kid into the bed.When the bed is in the up position, two metal latches attach the side panel on both the right and left side.When you put the side panel in the up position, it "clicks" into place.(example: (b)(6)) i put my son down for a nap.He does not sleep well and kicks at the side panel.When i put the side panel up, i heard the door click in and walked away to go take a shower.About 5-10 minutes, i heard him crying differently than normal (he usually cries hard every time he goes down for a nap or at bedtime); his cries sounded muffled.I didn't see him on the video monitor and found him face down on the floor.He does not roll over well and the floor was wet from his tears and snot.The fall was about 3 feet and he has very limited motor control.Luckily, he did not sustain any injuries but this could have been much worse.After i put him back in the bed, i put the panel back in the up position but noticed the left side latch did not latch to the closed position.I was able to jiggle it so it would close in place, so the "clicking" noise that i heard initially before the fall was only the right side clicking into place.I have spoken to both the supplier and manufacturer and they both seem kind and sympathetic over the phone.When i spoke to (b)(4) with sleepsafe, he told me (on (b)(6) 2019) that he knew of this problem and that the side panels were misleading when they "automatically" clicked into place, leaving consumers to think that the side panels were latched when they most certainly were not.This product only has a single point of failure with no safety/ secondary redundancy.This design is unacceptable and needs immediate attention and a warning issued to all caretakers and parents of this hazard.I had no warning of the hazard and only thought that the bed clicking into place meant the side panel was secure in place.This incident could have resulted in a serious injury to a little kid who has suffered so much already in a product that is designed to keep him safe while he sleeps.This hazard could be eliminated through design.My goal with this report is to require that sleepsafe issues a warning to all consumers that have this product and similar products and design safety redundancy into a critical component of their product.The name of the company is "sleep safe" and they should own that claim.Purchase date: (b)(6) 2018.(b)(4).

• Brand Name: SLEEPSAFE BEDS
• Type of Device: BED, MANUAL
• Manufacturer (Section D): SLEEPSAFE BEDS, LLC
• MDR Report Key: 9166814
• MDR Text Key: 161812505
• Report Number: MW5090268
• 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: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: S2-ME-CH-T
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 3 YR