Model Number MCH- 1000 (I) |
Device Problems
Alarm Not Visible (1022); Smoking (1585)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Due to user error and the low water level sensor not functioning as designed when a refrigeration module and an ice block are inside the tank, the device could be put in defrost mode without sufficient water.Thus, allowing the heating elements of the device to heat in a centralized area and damaging all internal components nearby.
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Event Description
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During quarterly disinfection of cardioquip modular cooler heater (mch).The mch began smoking and emitting a burning smell.No audible alarms or warning indicators occured.According to the service manual, "if the water level in the mch cold water tank falls below a safe operating level, the mch halts its operation, the low water level screen appears, and the alarm sounds a three-beep sequence every 8 seconds." this alarm was not triggered and did not occur.Per bmet, (b)(6): drained the mch, hit defrost mode, received temp differential error.The device was partially defrosted overnight.The next day, (b)(6) again placed mch in defrost mode (no water in device) and no temp diff error occurred this time.After 56 seconds, the ice block started defrosting quickly but then smoke started billowing out of the mch.Fire department had to be called.
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Manufacturer Narrative
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Further review determined that this is a non-reportable event.
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Event Description
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Customer reports smoke from device during defrost mode.
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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.During the investigation, cardioquip identified the heaters to be the source of the smoke as they melted the heater chamber bushings.The water level sensor that stops the device from running did not trigger due to the presence of ice.Ice can block the sensor and cause it to not trigger.All damaged components were replaced, and the device passed final inspection, and is fully functional.
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Event Description
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Customer reports smoke from device during defrost mode.
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Search Alerts/Recalls
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