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Catalog Number 0682001253 |
Device Problem
Temperature Problem (3022)
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Patient Problem
Burn(s) (1757)
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Event Date 02/10/2016 |
Event Type
Injury
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Manufacturer Narrative
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A stryker field service technician (sfst) went to the site and measured the lux values of the individual lights.The lux readings of each light individually was below 160 klux which is within the acceptable range per ul 60601-2-41 and the user manual, 1004400185 revision u section 11.4.Additionally, the sfst was informed that all three lights were focused on the same spot during use.When focused on the same spot the lux reading was 363 klux.During use 3 led lights were overlapped and caused heat generation.The user manual (1004-400-185) for the led lights warns against overlapping the lights as this will cause heat generation.Each light meets the specification called out by the user manual.The heat generation is from customer misuse of the product.
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Event Description
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It was reported that the led lights get hot during cases and allegedly burned two patients.Due to the alleged burns of patients, stryker will investigate and file a mdr for each light head.
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Manufacturer Narrative
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There has been corrected data updates made to the following fields: outcomes attributed to ae, reporting contact, component code grid, clinical signs code grid, health impact code grid, method code, results code, and conclusion code.
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Event Description
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It was reported that the led lights get hot during cases and allegedly burned two patients.Due to the alleged burns of patients, stryker will investigate and file a mdr for each light head.
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Search Alerts/Recalls
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