MAUDE Adverse Event Report: BEDS BY GEORGE BEDS BY GEORGE; HAVEN

Model Number 3000

Device Problems Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2019

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

User describes weak seam coming apart on a haven canoy on the back panel where the mesh is sewn in to the fabric.Due to this failure, the mesh pulled away form the fabric and produced a large opening in the back panel that made the bed unusable.It was concluded that it was a failure at the seam where the mesh was sewn to the fabric and a new canopy was provided at no charge.

• Brand Name: BEDS BY GEORGE
• Type of Device: HAVEN
• Manufacturer (Section D): BEDS BY GEORGE; 1045 n. nappanee street; elkhart IN 46514
• Manufacturer (Section G): BEDS BY GEORGE; 109 s. 14th ave; middlebury IN 46540
• Manufacturer Contact: mark salaiz ; 1045 n. nappanee street; elkhart, IN 46514 ; 5743332310
• MDR Report Key: 8964284
• MDR Text Key: 196437289
• Report Number: 3008830652-2019-00006
• 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 Health Care Professional
• 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: 3000
• Device Catalogue Number: 3000
• Device Lot Number: KNISKERN 061318
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2019
• Initial Date FDA Received: 09/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2018
• 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