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

Model Number 3500

Device Problems Product Quality Problem (1506); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2019

Event Type  malfunction  

Manufacturer Narrative

This mdr is in response to a recent fda audit request, specifically 'observation 1' from the fda's establishment inspection report.An mdr was not originally submitted due to a mis-understanding of the requirements for reporting and because no injuries were reported or sustained in the incident.It was unknown at the time that a product malfunction without injury was sufficient to require this mdr.We have since gone back and reviewed all previous claims under the correct standard and are thus submitting this report in compliance with that standard.

Event Description

The mesh on the canopy portion of the bed has ripped/torn in three places and is tearing away from seems.Review of the pictures provided showed the seems to secure the mesh to the fabric are sub-standard and the mesh has torn at those weak points.There has been no injury, however, the bed is not in usable condition as a result of the rips.It was determined the cause of this failure was a isolated manufacturing error and a new canopy was provided a no charge to the dealer.

Event Description

This is a follow-up with additional information from the original report.When initial event occured, beds by george personnel recommended that the child be placed in a bed with heavy duty mesh, suspecting the result of the original malfunction was due to the child's behavior and that standard mesh was not appropriate due to his level of activity.However the dealer and mother disagreed and thought the standard mesh was fine.Accordingly, against the recommendation of bbg personnel, they opted go with a standard mesh canopy and it was provided under warranty.On december 5, 2019, beds by george was informed by the dealer ((b)(4)) that the child had once again torn through the canopy mesh.Upon further investigation into the event, it was discovered and concluded that the child exhibits aggressive kicking behaviors and falls outside the design parameters intended for the standard mesh and it was determined that a standard mesh canopy is not appropriate for his use.Working with the atp, it was determined that a heavy duty mesh canopy is necessary for use with this patient and should have been used from the outset.Accordingly, it was determined this was not a product failure (but rather a misuse situation) and not a warranty situation.Bbg personnel informed the dealer that the family should discontinue using the bed until a new canopy is provided and subsequently provided the dealer with a quote for a new heavy duty mesh canopy.

Manufacturer Narrative

Original claim was not a warranty and was due to user error.There was not a manufacturing defect.Upon further information provided by user and dealer, the patient is outside the design parameters of the standard mesh canopy and the original failure of that mesh was due to user error.Attachment: [(b)(4) investigation (12-11-2019).Pdf, (b)(4) hd canopy zoho comments.Pdf].

• Brand Name: BEDS BY GEORGE
• Type of Device: SAFETY BED
• Manufacturer (Section D): BEDS BY GEORGE, INC.; 219 caravan drive; elkhart IN 46514
• MDR Report Key: 8960169
• MDR Text Key: 218742347
• Report Number: 3008830652-2019-00003
• Device Sequence Number: 1
• Product Code: OYS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 12/11/2019

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: 3500
• Device Catalogue Number: 3500
• Device Lot Number: PINEDA 062118
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 09/04/2019
• Supplement Dates Manufacturer Received: 12/05/2019
• Supplement Dates FDA Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention