Model Number 3000 |
Device Problems
Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/11/2019 |
Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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User describes weak seam coming undone on a haven canopy where the mesh is sewn to fabric.As a result of this seam failure, the mesh pulled away from the fabric and began to tear.The result was a large opening in the mesh in the door that made the bed no longer usable.This was concluded to be a failure of the seams/mesh and a new canopy was provided at no charge and asap.
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Search Alerts/Recalls
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