Model Number INTEGRIS ALLURA 15 & 12 MONOPLANE |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/26/2022 |
Event Type
Injury
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Event Description
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It has been reported to philips that, the mavig lead shield fell from ceiling mount.No patient injury/harm was reported to philips.Philips has started an investigation of this complaint.
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Manufacturer Narrative
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Philips has investigated this complaint.The philips field service engineer (fse) inspected the system onsite and confirmed that lead shield separated from the ceiling mount at the swivel union and fell but the doctor was able to catch the lead shield before it hit the patient.Upon functional test fse found safety collar had become detached/loose from the arm.Mavig lead shield and arm were replaced by a third party service provider.After replacement the entire arm and shield, the system was returned to use in good working order.The codes were updated based on the investigation outcome.
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Search Alerts/Recalls
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