Model Number PWD500 |
Device Problems
Detachment Of Device Component (1104); Fracture (1260)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/15/2016 |
Event Type
malfunction
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Manufacturer Narrative
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A maquet field service technician (fst) evaluated the device and found that the spring arm failed.The casting sheared at the cupola (lighthead) end of the spring arm.The investigation is on-going and the result will be included in a follow-up report.The room has been taken out of service, pending repair.
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Event Description
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The customer reported that the operating lights' spring support arm fractured while repositioning it, leading to the failure and detachment of the spring arm supported only by the supply cable.There was no patient involved and there was no injury reported.(b)(4).
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Manufacturer Narrative
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(b)(4).Exemption # e2018005.(b)(4).The manufacturing site was made aware of additional information on 16aug2016.This new awareness date was previously omitted from the previous follow-up report in error.
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Event Description
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Manufacturer reference # (b)(4).
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Manufacturer Narrative
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(b)(4).Exemption # e2018005 (b)(4).A maquet field service technician (fst) evaluated the device and found that the spring arm failed.The detachment was caused by the breakage of the spring arm front pivot.No similar incident with a similar root cause has been recorded by maquet sas.The field service technician replaced the spring arm with a new one and returned the device to service.The supplier has retraced the impacted series and has blocked the affected components and final assembly groups, load tests with material from the warehouse stock, done an evaluation of the error pattern with their supplier and performed x-ray inspection on their stock impacted.The supplier evaluated the spring arm with analysis of material and x-ray inspections and no material weakness were detected on this spring arm.Maquet assumes that the fracture of the spring arm was caused by an improper use of the device and a combination of repetitive mechanical stresses.
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Event Description
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Manufacturer reference # : (b)(4).
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Search Alerts/Recalls
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