Model Number MCH-1000(M) |
Device Problems
Device Emits Odor (1425); Shipping Damage or Problem (1570); Device Operates Differently Than Expected (2913); Insufficient Information (3190)
|
Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/20/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
This report is being submitted to replace report number mw5068335, submitted on 03/06/2017.
|
|
Event Description
|
The customer had called reporting the unit was not working properly, and that the nurse noted a "smell of smoke".The customer was sent a new unit, the unit in question was investigated and was found to have shipping damage.Upon further inspection of the unit, the manufacturer was unable to produce either the smell or the appearance of smoke from the unit.
|
|
Manufacturer Narrative
|
This report is being submitted to replace report number mw5068335, submitted on 03/06/2017.
|
|
Event Description
|
The customer had called reporting the unit was not working properly, and that the nurse noted a "smell of smoke".The customer was sent a new unit, the unit in question was investigated and was found to have shipping damage.Upon further inspection of the unit, the manufacturer was unable to produce either the smell or the appearance of smoke from the unit.
|
|
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 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.
|
|
Event Description
|
Customer reports the unit was not working properly, and the nurse noted a "smell of smoke.".
|
|
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 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.
|
|
Event Description
|
Customer reports the unit was not working properly, and the nurse noted a "smell of smoke.".
|
|
Search Alerts/Recalls
|