MAUDE Adverse Event Report: SLEEPSAFE BEDS SLEEPSAFE; SAFETY BED

Model Number SLEEPSAFER

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 11/15/2021

Event Type  Injury  

Manufacturer Narrative

Sleepsafe distributes to the dme.Dme sets up and installs in the end-user home.Dme has affirmed they will include us in the investigation.On 12/15/2021 has dme evaluated the bed and found no deficiency with latching.

Event Description

Mom advised durable medical equipment [dme] provider saying she was putting child to bed, flipped up safety rail, not being sure the latch was engaged, child began kicking.While kicking, he possibly kicked down the safety rail, his body flexed around and he slid off edge of bed resulting in a leg injury which required casting.Dme visited home and advised us [sleepsafe] that no deficiency was found with the latching.Most likely cause is rail was down or otherwise not latched at the time of the event.

• Brand Name: SLEEPSAFE
• Type of Device: SAFETY BED
• Manufacturer (Section D): SLEEPSAFE BEDS; 3629 reed creek drive; bassett VA 24055
• Manufacturer (Section G): SLEEPSAFE BEDS; 3629 reed creek drive; bassett VA 24055
• Manufacturer Contact: robert baldacci ; 3629 reed creek drive; bassett 24055 ; 8668522337
• MDR Report Key: 13095017
• MDR Text Key: 282899508
• Report Number: 3008061384-2021-00001
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 10860000213452
• UDI-Public: (01)10860000213452
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SLEEPSAFER
• Device Catalogue Number: SR-ME-MC-T
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/12/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 7 YR
• Patient Sex: Male
• Patient Weight: 29 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White