Model Number 8015 ALARIS PCU 1.5 MODULE |
Device Problems
Contamination (1120); Misassembled (1398); Therapeutic or Diagnostic Output Failure (3023); No Apparent Adverse Event (3189)
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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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Note: this event was inadvertently reported under incorrect product registration number (manufacturer report number 9616066-2020-02843.This mdr resubmission now reflects the correct product registration number.The customer reported problem was confirmed.The device was repaired, passed all required testing and specifications, and released back to the customer.A review of the device history record for sn (b)(4) was performed from 03/19/2019 to 08/30/2020 and note that this device has been returned for service 1 time without correlation to the customer reported issue or service repair.Also, there were no production failures indicated on the source device.
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Event Description
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Failed preventive maintenance.Keypad- fluid ingress/contam.
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Manufacturer Narrative
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Addition: updated adverse event codes (h6).
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Event Description
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Failed preventive maintenance keypad fluid ingress/contam.
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Search Alerts/Recalls
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