Model Number HL-90 |
Device Problem
Failure to Power Up (1476)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Event Description
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It was reported that the device would not power up.Patient involvement unknown.
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Manufacturer Narrative
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Other text: b3: date of event and d4: udi number 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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Manufacturer Narrative
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One device was returned for investigation.The enclosure and tank cover was cracked and the drain fitting was corroded.The device was functionally tested where the customer complaint of a power issue was confirmed.This was traced to an issue with the printed circuit board causing the power switch leads to break off.The device was not repaired due to it being beyond economical repair and was scrapped.The product's history records were reviewed and there were no non-conformance's nor service-related issues that would have resulted in the reported complaint.
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Search Alerts/Recalls
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