|
Model Number MCH-1000(M) |
Device Problems
Excessive Cooling (2932); Activation Problem (4042)
|
Patient Problems
Abdominal Pain (1685); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/07/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
An investigation was conducted on the mch-1000(m), where it was noted that the device had not been serviced by a cardioquip certified technician in over 2 years.Upon inspection, it was discovered, through the use of an electrical safety analyzer, that the leakage current tested over 100[?]a and that the 1600w heater was shorting internally to its chassis, which caused the "main heater" failure alarm.After speaking with the ecmo coordinator, she was not able to definitively identify that the cardioquip mch-1000(m) caused the patients discomfort.She believed that the delivery of colder water to the patient might have caused the abdominal discomfort.The 1600w heater was replaced, and the mch-1000(m) passed a full inspection.
|
|
Event Description
|
Ecmo coordinator reported a "heater failure" alert on the start-up screen.However, the unit had been in standby mode and was connected to an ecmo circuit at the time.When the clinician pressed "run" on the cardioquip, it went into "system test" and resulted in the "heater failure" alarm.Also, the patient reported sharp pain in the abdomen.The clinician stated that while in standby, the water would have cooled to room temperature and the delivery of the colder water to the patient caused the sharp pain in the abdomen of the patient which resulted in the discomfort.The clinician ultimately swapped out the unit.
|
|
Event Description
|
Customer reports that the unit goes to back to "standby" mode after being put into run mode during a case.The customer attempted to run the unit multiple times afterwards, each time running only for one minute or less before going back into standby mode.
|
|
Manufacturer Narrative
|
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.The issue was unable to be replicated during investigation.Although unrelated to the issue described by the customer, cardioquip identified the 1600w heater as requiring replacement.Following replacement, the device passed inspection and is fully operational.
|
|
Search Alerts/Recalls
|
|
|