DRAEGER MEDICAL SYSTEMS, INC INFINITY ACUTE CARE SYSTEM (M540); PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT
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Catalog Number MS25520 |
Device Problem
Low Readings (2460)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Additional information was requested, however; a response was not received.It was not stated upon initial reporting that the patient experienced a serious injury or required medical intervention as a result of the reported issue.No device was returned to the manufacturer for physical evaluation or logs for visual inspection.Without the device or information, it is not possible to perform root cause analysis.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
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Event Description
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The customer reported that the m540 was not correctly reading an infant's o2 saturations.The m540 showed that the infant had a o2 saturation of 37%, however; the patient was awake and conscious, with a normal heart rate and not showing low o2 symptoms.The customer replaced the o2 saturation probe, and the reading remained the same.The biomed stated that there is no event/patient information as the devices were received on their desk with no additional information.There is no information stating there is any adverse patient impact or delay in treatment.
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Search Alerts/Recalls
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