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

Model Number S2

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Limb Fracture (4518)

Event Date 03/22/2022

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 300648742
• Report Number: 3008061384-2022-00001
• Device Sequence Number: 1
• Product Code: FNJ
• UDI-Device Identifier: 10860000213742
• UDI-Public: 10860000213742
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

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