Model Number 8100 |
Device Problem
Break (1069)
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Patient Problem
Not Applicable (3189)
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Event Type
malfunction
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Manufacturer Narrative
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No device will be returned per customer.The customer complaint could not be confirmed because the device was not sequestered for failure investigation.The root cause of this failure was not identified.
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Event Description
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It was reported that the design and the quality of the plastics are a high failure, which is very costly, making it very high cost to ownership product as the door breaks far too often.There was no patient involvement reported in this event.
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Manufacturer Narrative
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Correction: disregard file (after further review it was decided that the issue is a non reportable malfunction).
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Event Description
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It was reported that the design and the quality of the plastics are a high failure, which is very costly, making it very high cost to ownership product as the door breaks far too often.There was no patient involvement reported in this event.
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Search Alerts/Recalls
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