Model Number HL-90 |
Device Problems
Failure to Power Up (1476); Power Problem (3010)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Date of event and udi section are 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 warmer will not power on.Patient involvement is unknown.
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Manufacturer Narrative
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Other text: b5: additional information and h6.Health impact codes, updated.
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Event Description
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Additional information received via email.No patient involvement was reported.
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Manufacturer Narrative
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Device evaluation: one device was returned for investigation.Visual inspection found a cracked enclosure, cracked tank cover, corroded drain fitting, and outdated printed circuit board (pcb) and outdated power switch.Functional testing confirmed the complaint.The connection between the pcb and power switch had become disconnected because of wear and tear from daily use.Root cause was attributed to design.A manufacturing device history report (dhr) review was not performed because the device is beyond a year from its manufacture date and there was no indication of a manufacturing defect during the investigation.Service history review identified this device has not been in for service previously.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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