Model Number CARDIOHELP-I |
Device Problems
Communication or Transmission Problem (2896); Device Sensing Problem (2917); Infusion or Flow Problem (2964)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/08/2024 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge service technician will investigate the affected cardiohelp.A follow-up medwatch will be submitted when additional information becomes available.
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Event Description
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It was reported that the flow bubble sensor had a malfunction.It was unable to be calibrated.Complaint id # (b)(4).
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Manufacturer Narrative
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A getinge field service technician (fst) was sent for investigation on 2024-03-06.The flow/bubble sensor was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.A follow-up medwatch will be submitted when additional information becomes available.
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Event Description
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Complaint id # (b)(4).
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Search Alerts/Recalls
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