Model Number MCH-1000(M) |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/20/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The manufacturer is reporting the following complaint after a voluntary review of all complaints (reportable or not) since 2016.This report is being filed now, after being scrutinized under a newly revised risk matrix, recently adopted after inspection.The unit was still under warranty and a replacement unit was sent to the customer.Cardioquip service received the device and inspected the unit.The only component that was nonfunctioning was the screen.The screen was repaired, a final inspection was performed, and passed for full functionality.
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Event Description
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Customer reports the unit was not working properly, and the nurse noted a "smell of smoke.".
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Manufacturer Narrative
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The manufacturer is reporting the following complaint after a voluntary review of all complaints (reportable or not) since 2016.This report is being filed now, after being scrutinized under a newly revised risk matrix, recently adopted after inspection.This report is a duplicate of a report previously filed under 3007899424-2017-00002.
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Event Description
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Customer reports the unit was not working properly, and the nurse noted a "smell of smoke.".
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Search Alerts/Recalls
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