Model Number MCH-1000(M) |
Device Problems
Insufficient Heating (1287); Naturally Worn (2988); Insufficient Information (3190)
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Patient Problems
Alteration in Body Temperature (4568); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/22/2020 |
Event Type
malfunction
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Event Description
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The extracorporeal membrane oxygenation (ecmo) heater clicked into test mode during cannulation.Water was added and seemed to be functioning appropriately at that time.About an hour later, it was noted that the heater temperature was 30 degrees celsius and the patient's temperature decreased.The heater was exchanged with another and sent to our biomedical engineering team to investigate.
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Manufacturer Narrative
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Upon inspection of the device, it was found that the insulation around the wires of the 1600w heater was compromised, allowing the wires to become exposed.The exposed wires made contact with the chassis of the device, thus causing an electrical short to occur which cycled power to the device.This event returns the device to self-test mode, as described by the user.The device was repaired, and passed a full inspection.The cause of the compromised insulation around the 1600w heaters was addressed in manufacturing.
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Event Description
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User facility report number: (b)(4).
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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 customer notified cardioquip, that a patient was involved during the malfunction although no patient information was communicated.Cardioquip's investigation determined that the heater was nonfunctional.Following replacement, the device passed inspection, and is fully operational.
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Event Description
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Customer reports that the unit's delivery temperature suddenly dropped while on a patient, and that the unit suddenly cycled power.When running the unit overnight, the temperature went over the set temp.
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Search Alerts/Recalls
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