MAUDE Adverse Event Report: BEDS BY GEORGE, INC. BEDS BY GEORGE; S1700

Model Number S1700

Device Problems Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)

Patient Problem Limb Fracture (4518)

Event Date 09/15/2022

Event Type  Injury  

Event Description

(b)(6), mom, messaged us on facebook late (b)(6) (10:44 pm) alerting us that her 3 y.O.Unlatched the door of her other son's (user's) bed and opened it onto the user in the bed and broke his ankle.Both in the message on facebook and in a subsequent call, ms.(b)(6) informed us that she had removed the springs that assist to operate the door and also are fail safe that the door will not open by itself when unlatched.We later discussed this issue where she admitted to removing the springs and then subsequently refused service from her dealer whom we had sent a new spring change kit on her son's beds behalf at the request of the dealer.Accordingly, at the time of the event, there were no springs in the tracks as the required by the bed's design and for proper use.This allowed her 3 y.O.To then go unsupervised to the bed, unlatch the door, and without the spring assist, the door was able to open on the user inside, causing injury to his ankle that became wedged betweent he bi-folding door.After a long discussion with her after the fact, it was agreed we would send another spring change kit directly to her as well as barrel bolt latches to change out to use instead of the standard slide latch.This would ensure a non-authorized user would be able to operate the door in the event the springs were still not installed.In addition to this, we informed ms.(b)(6) that she should not be using the bed in its current condition and to not use it again until such time as it could be repaired and put back into proper working order.She informed us she had ceased using the bed since the incident and would not use it again until the repair had been made and the dealer was able to do an inspection to make sure the bed is in proper and safe working order.Finally, we informed (b)(6) in service at the dealer of the issue as well as having a discussion the service manager, and they assured us they would be following up with family again to coordinate repair and inspection of the bed.

Manufacturer Narrative

User was informed of the user error issues with removing the springs from the door and then disregarding the dealer's request to repair.She was informed this was a mitigating circumstance as to why the door was allowed to open as it did and was not in proper working order.To assist the family, bbg sent repair parts as well as a latch conversion kit directly to the family to fix the bed prior to it being used.This will ensure both that an unintended caregiver like a child cannot open the door and that the bed is in safe working order.This was also communicated to the dealer so they could coordinate with the family to assist with the repair and inspection of the device.

• Brand Name: BEDS BY GEORGE
• Type of Device: S1700
• Manufacturer (Section D): BEDS BY GEORGE, INC.; 219 caravan drive; elkhart IN 46514
• Manufacturer (Section G): BEDS BY GEORGE, INC.; 109 14th ave.; s building 2; middlebury IN 46540
• Manufacturer Contact: adam davis ; 219 caravan drive; elkhart, IN 46514 ; 5743332310
• MDR Report Key: 15553736
• MDR Text Key: 301351992
• Report Number: 3008830652-2022-00001
• Device Sequence Number: 1
• Product Code: OYS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 09/29/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: S1700
• Device Catalogue Number: 1700
• Device Lot Number: AY 051818-1
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male