Model Number HL-90 |
Device Problem
Power Problem (3010)
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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 power cord terminals housing was defective.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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Email is: (b)(6).Evaluation codes: updated.Device evaluation: one device was returned for investigation.Visual inspection found a broken pole clamp and cracked tank cover.Outdated printed circuit board (pcb) and power switch.Functional testing found the device has no power when plugged into power source and the power switch turned on; confirming the customer complaint.Root cause was attributed to the terminal strip on the pcb where the power cord wires are attached being damaged.What caused the damage could not be established.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.No action taken due to the condition of the device.It is deemed beyond economical repair and will be scrapped.
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Search Alerts/Recalls
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