MAUDE Adverse Event Report: BEDS BY GEORGE, INC. BEDS BY GEORGE; HAVEN 3000

Model Number 3000

Device Problems Crack (1135); Nonstandard Device (1420); Material Separation (1562); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

After extensive review, device did not meet manufacturing guidelines/quality for proper sewing of canopy.This was an oversight by our sewing department that missed the stitch line, causing the mesh to be weaker in the foot panel.This is a warranty as a manufacturing defect and a new canopy is being provided to user.

Event Description

Atp for beds by george (bbg) dealer (national seating & mobility in (b)(6)) sent an e-mail on 11/10/21 informing bbg that the mesh in the foot section of their haven canopy (bed) had pulled away from the fabric, creating a substantial hole/tear/opening.The atp stated that he saw the hole in the canopy a couple of weeks prior and it was much smaller.About 4 inches according to him but has since become larger.Bbg was not notified about the original hole, and was not notified of any damage until 11/20.Mom told atp that the rip is from the user pushing & kicking (she is aggressive) but does not feel that an implement was involved to start the hole.Atp states that the user is (b)(6) & very powerful.Atp provided pictures to bbg; and after extensive review of the pictures and further investigation which included review of the pictures with bbg's head designer and discussion with the sewing department, it has been determined that this canopy does not meet bbg's quality production standards and was not sewn correctly.In specific, the canopy in question uses bbg's 'heavy duty' (hd) mesh product.This is nearly twice the strength of standard mesh and is designed for users such as this, subjectively much stronger than even this user.In fact, to date, there have been zero failures of bbg's hd mesh product.However, when reviewing the pictures, it shows that the sewing department missed a stitch line for the reinforcement backing that reinforces the mesh with a backing to the fabric for strength.This is a double stitch line for extra strength and the stitch line that was sewn missed the backing and mesh in this area, leading to the mesh being able to pull away with the kicking behavior.This was likely not to occur if the stitch line had been sewn correctly.

• Brand Name: BEDS BY GEORGE
• Type of Device: HAVEN 3000
• 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: angela faubion ; 219 caravan drive; elkhart, IN 46514 ; 5743332310
• MDR Report Key: 12812847
• MDR Text Key: 288106022
• Report Number: 3008830652-2021-00001
• 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: Other
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3000
• Device Catalogue Number: 3000
• Device Lot Number: N. EVA 011121-2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2021
• 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): Other
• Patient Age: 11 YR
• Patient Sex: Female
• Patient Weight: 23 KG