Model Number MCH-1000(R) |
Device Problems
Device Emits Odor (1425); Sparking (2595)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/28/2021 |
Event Type
malfunction
|
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.Cardioquip's investigation determined the temperature controller and the relay to be the issue.After replacing the temperature controller and the relay, the device passed inspection and is fully operational.
|
|
Event Description
|
During pm inspection technician was notified the plug began sparking when plugged in and intermittent clicking occurred causing a burnt smell in the air.This was shortly after a cleaning procedure.
|
|
Manufacturer Narrative
|
Further review determined that this is a non-reportable event.
|
|
Event Description
|
During pm inspection technician was notified the plug began sparking when plugged in and intermittent clicking occurred causing a burnt smell in the air.This was shortly after a cleaning procedure.
|
|
Search Alerts/Recalls
|