Model Number VLT64DFSTP |
Device Problems
Detachment Of Device Component (1104); Corroded (1131)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/08/2016 |
Event Type
malfunction
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Manufacturer Narrative
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A maquet field service technician evaluated the device and found that the spring arm is rusted.The investigation is on-going and the result will be included in a follow-up report.
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Event Description
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While maquet field service technician was performing a routine maintenance on a surgical light he found that the spring arm was rusted and some particles fell off.There were no injuries reported.(b)(4).
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Manufacturer Narrative
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Maquet evaluated the device and determined that the device failed to meet its specification due to a poor painting process.Investigations were conducted at the suppliers' and maquet was able to verify that the painting process is validated and therefore concludes to an isolated error at the suppliers' on this particular unit.Additionally the device is directly involved with the reported incident and however was not being used for treatment or diagnosis on patient when the event occurred.The volista series operating manual indicates that users should "check the system for impact marks and other surface damage" on a daily basis.
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Event Description
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Factory reference number: (b)(4).
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Search Alerts/Recalls
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