inforMED
MalfunctionBZC

VYNTUS BODY

Received Apr 24, 2025 · Event occurred Mar 10, 2025

Report 9615102-2025-00171 · MDR key 21897513

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Product code (BZC)
Model (VYNTUS BODY)

Device

Generic name

Calculator, Pulmonary Function Data

Model number

VYNTUS BODY

Catalog number

V-178500-13

Product problems

  • Break
  • Break

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT DURING INSTALLATION OF THE VYNTUS BODYBOX DOOR THE DOOR FELL ON THE SERVICE TECHNICIAN. THERE WAS NO PHYSICAL HARM TO THE SERVICE TECHNICIAN BESIDES FRAGMENTS OF GLASS ENTERING HIS HAIR AND FOOTWEAR. IT WAS CONFIRMED THAT THE TECHNICIAN WAS NOT WEARING THE NECESSARY SAFETY CLOTHING (E.G. SAFETY GLOVES, SAFETY GOGGLES) FOR THE INSTALLATION OF A VYNTUS BODYBOX.

Additional Manufacturer Narrative

THE SHATTERED VYNTUS BODYBOX DOOR WAS NOT RETURNED FOR AN INVESTIGATION AND ALSO NO PICTURES WERE PROVIDED. THE SERVICE TECHNICIAN INVESTIGATED WHAT WAS LEFT FROM THE DOOR AND DISCOVERED THAT THE BOTTOM HINGE ON THE BODY BOX HAD A CRACKED BLACK INSERT SLEEVE WHICH MIGHT CONTRIBUTED THE SAFETY GLASS TO BREAK. THE RISK OF A BODYBOX DOOR SHATTERING DURING INSTALLATION IS COVERED IN THE RISK MANAGEMENT FILE. TO REDUCE THE RISK SAFETY GOGGLES AND SAFETY GLOVES MUST BE WORN DURING INSTALLATION TO MINIMIZE THE SEVERITY OF HARM. AS NO SAFETY CLOTHING WAS WORN IN THIS CASE, THERE WAS NO RISK REDUCTION AND THERE IS A POTENTIAL RISK OF IMPAIRED VISUAL FUNCTION, WHICH IS WHY THIS INCIDENT WAS CLASSIFIED AS A REPORTABLE INCIDENT. THE SUPPLIER WAS INFORMED ABOUT THE INCIDENT AND CONFIRMED THAT THERE WERE NO ANOMALIES DURING PRODUCTION. IN ADDITION, THERE ARE NO KNOWN FAULTS REGARDING BROKEN BUSHINGS IN THE DOOR HINGES AND NO CRACKS IN THE DOOR GLASS HAVE BEEN REPORTED DURING PRODUCTION. IT IS ASSUMED THAT THE FAULT ON THE HINGE OCCURRED DURING TRANSPORTATION AND CAUSED THE SAFETY GLASS TO CRACK DURING INSTALLATION. AS A RESOLUTION A NEW VYNTUS BODYBOX DOOR WAS DELIVERED TO THE CUSTOMER AND INSTALLED ON (B)(6) 2025. THE RISK EVALUATION RESULTS IN A RISK ACCEPTANCE LEVEL OF A MEDIUM ACCEPTABLE HEALTH RISK.

Remedial action

  • Replace