MAUDE Adverse Event Report: SLEEPSAFE BEDS SLEEPSAFE; SAFETY BED [HOSPITAL BED]

Model Number	S2
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	03/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Resubmitted (b)(6) 2022.(b)(6) [pt] advised that dexter has broken his wrist while in a sleepsafe bed.Dexter's grandfather alleged that dexter had his hand wedged between the mattress and the panel and speculates that dexter twisted and broke his wrist.(b)(6) advised that grandfather was told by the nurses that dexter wedges his hand down there "all the time." arranged for grandfather ((b)(6)) to call sleepsafe.Grandfather advises that he was told by the rn that the nurse pulled dexter's hand out of the gap and did not notice any signs of injury at that time.Apparently no one witnessed the event.Grandfather advises that dexter is a complex care child.Grandfather further advised that there is an osteo diagnosis and that this may have contributed to susceptibility to this type injury.We called the dme (all about pediatrics) requesting that the bed be evaluated.Dme inspected and advised that the zone 3 / 5 gaps look proper per design.

• Brand Name: SLEEPSAFE
• Common Device Name: SAFETY BED [HOSPITAL 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, VA 24055 ; 8668522337
• MDR Report Key: 15487173
• Report Number: 3008061384-2022-00001
• Device Sequence Number: 6511625
• Product Code: FNJ
• UDI-Device Identifier: 10860000213742
• UDI-Public: 10860000213742
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: S2
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 8 YR
• Patient Sex: Male
• Patient Race: White