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Model Number HL-390 |
Device Problems
Device Alarm System (1012); Leak/Splash (1354); Overheating of Device (1437)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Manufacturer Narrative
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B3: date of event is unknown.No information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr, 803.56, when additional reportable information becomes available.
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Event Description
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It was reported, that the unit had a high temperature.Was alarming and a small leak underneath.Patient involvement unknown.
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Manufacturer Narrative
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Device evaluation: one device was returned for investigation in used condition.Visual inspection showed a cracked tank cover.Device was filled with water and run where the customer complaint of a leak was confirmed.The complaint of device over temping could not be confirmed, the temperature rose to a normal level.The tank cover was replaced and the printed circuit board as well for preventative measure.The device was calibrated and ran again, passing all functionality tests.No root cause of what caused the crack and the leak was confirmed.Device history review was not done as the device was beyond a year from the manufacturing date.Service history review shows device had not been in for service previously.
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Search Alerts/Recalls
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