Catalog Number 103453 |
Device Problem
Imprecision (1307)
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Patient Problems
Chest Pain (1776); Dyspnea (1816); Blood Loss (2597)
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Event Date 01/19/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that a phoenix machine.Did not detect air bubbles during patient treatment.The patient presented with cough, thoracic pain and shortness of breath.The patient was in pain for five minutes and was treated by administering oxygen.It was reported that the patient was walking without assistance after treatment and no hospitalization was required.No additional information is available.
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Manufacturer Narrative
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The device was evaluated on site by a qualified technician.Visual inspection found the patient sensor was out of calibration range.The reported condition was verified.A functional check was performed and the patient sensor was calibrated and cleaned.An electrostatic discharge test was performed and passed.The abd (air bubble detector) sensor device was received for evaluation.Visual inspection observed that the abd had increased sensitivity.The cause of the condition was not determined.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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