Model Number 383400 |
Device Problems
No Audible Alarm (1019); No Display/Image (1183)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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A non-specific issue was reported by the customer.On (b)(6) 2018, the unit was triaged and service found that the screen was blank.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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The unit was triaged and the reported condition was confirmed.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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