CARDIOQUIP MODULAR COOLER HEATER
Report
- Report Number
- 3007899424-2017-00002
- Event Type
- Malfunction
- Date Received
- October 12, 2017
- Date of Event
- January 20, 2016
- Report Date
- June 30, 2022
- Manufacturer
- CARDIOQUIP, LLC
- Product Code
- DWC
- PMA / PMN Number
- K102147
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
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.
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.
CUSTOMER REPORTS THE UNIT WAS NOT WORKING PROPERLY, AND THE NURSE NOTED A "SMELL OF SMOKE."
CUSTOMER REPORTS THE UNIT WAS NOT WORKING PROPERLY, AND THE NURSE NOTED A "SMELL OF SMOKE."
THIS REPORT IS BEING SUBMITTED TO REPLACE REPORT NUMBER MW5068335, SUBMITTED ON 03/06/2017.
THIS REPORT IS BEING SUBMITTED TO REPLACE REPORT NUMBER MW5068335, SUBMITTED ON 03/06/2017.
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.
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 722850 | CARDIOQUIP MODULAR COOLER HEATER | CARDIOPULMONARY BYPASS DEVICE | DWC | CARDIOQUIP, LLC | MCH-1000(M) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |