Model Number HL-90 |
Device Problem
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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Other text: b3: date of event is unknown, no information has been provided to date.Udi section of d4 is unknown.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 was overheating.There has been no report of patient involvement.
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Manufacturer Narrative
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Device available for evaluation; h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.One device was received.Visual inspection noted a broken front cover, outdated printed circuit board (pcb) and power switch.Per functional testing the temperature of the device was running high confirming the complaint.The root cause was the device was out of calibration.The temperature pot on the pcb was adjusted and the temp was lowered.It was unknown what caused the condition.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.No action taken due to the condition of the device.It was deemed beyond economical repair and was scrapped.
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Search Alerts/Recalls
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