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

Model Number 3500

Device Problems Mechanical Problem (1384); Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2018

Event Type  malfunction  

Manufacturer Narrative

This mdr is in response to a recent fda audit response, 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

Zipper mechanism (specifically the teeth) on the door of a haven canopy will not remain zipped in the bottom right corner section of the door.The zipper moves fine back and forth to open and close (engage) the zipper teeth, however, the teeth will not remain engaged.Through pictures and a video it has been determined that the zipper mechanism is faulty and is malfunctioning and a replacement canopy was provided.Their were no injuries but the product (zipper) did malfunction and is not working properly.

• Brand Name: BEDS BY GEORGE
• Type of Device: HAVEN
• Manufacturer (Section D): BEDS BY GEORGE, INC.; 1045 n. nappanee st.; elkhart IN 46514
• Manufacturer (Section G): BEDS BY GEORGE, INC.; 109 14th ave; s building 2; middlebury IN 46540
• Manufacturer Contact: adam davis ; 1045 n. nappanee st.; elkhart, IN 46514 ; 5743332310
• MDR Report Key: 8962215
• MDR Text Key: 218742012
• Report Number: 3008830652-2019-00004
• 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: company representative
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/04/2019

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: SOMOZA 041217
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/19/2018
• Initial Date FDA Received: 09/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2017
• 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