CARDIOHELP
Report
- Report Number
- 8010762-2025-0000535
- Event Type
- Malfunction
- Date Received
- December 2, 2025
- Date of Event
- November 25, 2025
- Report Date
- January 13, 2026
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTQ
- UDI-DI
- 4037691658384
- PMA / PMN Number
- K133598
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A GETINGE SERVICE TECHNICIAN WILL INVESTIGATE THE AFFECTED CARDIOHELP. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE UNITED KINGDOM MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "BASE UNIT, CARDIOHELP¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K133598. FOR SECTION D4 ALL AVAILABLE IDENTIFYING INFORMATION IS FOR THE OUT OF THE US DEVICE, SUBJECTED TO THIS REPORT. THEREFORE, NO GUDID INFORMATION EXISTS. FURTHERMORE, UDI INFORMATION (PRIMARY DI NUMBER) PROVIDED IN D4 IS FOR CARDIOHELP WITH CATALOG NUMBER 701048012.
INFORMATION RECEIVED ON 2025-12-08, THAT THE FAILURE OCCURRED DURING PRIMING. A GETINGE SERVICE TECHNICIAN WILL INVESTIGATE THE AFFECTED CARDIOHELP. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
THE EVENT OCCURRED IN UK DURING TREATMENT. IT WAS REPORTED THAT BOTH BATTERIES ARE DEFECTIVE AND THE CARDIOHELP DOES NOT FUNCTION UNLESS IT IS CONNECTED TO THE AC MAINS POWER. NO HARM TO ANY PERSON HAS BEEN REPORTED. INFORMATION RECEIVED ON 2025-12-08, THAT THE FAILURE OCCURRED DURING PRIMING. AS THE FAILURE WAS FOUND PRIOR TO TREATMENT, AND NO PATIENT INVOLVEMENT WAS REPORTED. THEREFORE, THIS COMPLAINT IS NO LONGER REPORTABLE. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION ON 2025-01-12. THE BATTERIES WERE REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. ACCORDING TO THE FST, THE CUSTOMER DOES NOT CALIBRATE THE BATTERIES EVERY FOUR MONTHS ACCORDING TO THE INSTRUCTION FOR USE OF THE CARDIOHELP. (REFER TO COMMUNICATIONS GRID). ACCORDING TO THE RISK FILE V24 OF THE CARDIOHELP DEVICE THE FOLLOWING ROOT CAUSES CAN LEAD TO THE REPORTED FAILURE: - USER OMITS TO CONDUCT THE BATTERY CALIBRATION WHEN IT IS DUE (EVERY 4 MONTHS) OR PERFORMS IT INCORRECTLY, - DEVICE WITH UNCALIBRATED BATTERY - ADDITIONAL CONDITION: BATTERY RUNS OUT EARLIER THAN EXPECTED DURING APPLICATION. THE COMPLAINT INFORMATION WAS TRANSFERRED TO THE INTERNAL NONCONFORMITY PROCESS. THE NC IMPLEMENTS THAT DUE TO LONGER STANDBY TIME OF THE CARDIOHELP THE BATTERY CAPACITY SUFFERS. THIS LEADS TO FOLLOWING: - STRONGLY DEVIATING CAPACITY LEVELS OF THE DEVICES. - BATTERIES LOCKED FOR CHARGING. - FAILED BATTERY CALIBRATION WITH 'TIMEOUTS'. - EXCESSIVE SELF-DISCHARGE. - APPARENTLY CAUSELESS DEEP DISCHARGE. THE ROOT CAUSE IS A NON CONFORMITY OF THE COULOMB COUNTING METHOD FOR DETERMINATION OF THE STATE OF CHARGE. THE CARDIOHELP SYSTEM HAS TWO REDUNDANT BATTERIES WITH 2 SEPARATED BATTERY SLOTS. THE SYSTEM IS CAPABLE TO OPERATE WITH 1 BATTERY. THE REDUNDANT DESIGN OF TWO USABLE BATTERIES AND THE ALARMING ABOUT DEFECT BATTERIES CAUSE A HIGH LEVEL OF SAFETY. ACCORDING TO THE INSTRUCTION FOR USE, CHAPTER "CHECK BEFORE EVERY USE", THE USER SHOULD ONLY START THE APPLICATION WHEN THE BATTERIES OF THE CARDIOHELP ARE FULLY CHARGED AND CALIBRATED. THE CALIBRATION OF THE BATTERIES HAS TO BE PERFORMED AT LEAST EVERY 4 MONTHS AS DESCRIBED IN THE IFU CHAPTER ¿CALIBRATING THE BATTERIES¿. IF NOT USED DURING TRANSPORTATION THE BATTERIES ARE A BACKUP POWER SUPPLY FOR THE AC/DC POWER SUPPLY VIA CABLE. THE REVIEW OF THE NON-CONFORMITIES (NC) HAS BEEN PERFORMED ON 20256-01-08. THE DEVICE WAS MANUFACTURED ON 2020-04-28. FOLLOWING NCS REGARDING THE REPORTED FAILURE WERE FOUND: BATTERY CAPACITY AND CHARGING PROBLEM. IN ADDITION, A REVIEW FOR POTENTIAL FIELD ACTIONS AND CAPAS RELATED TO THE FAILURE AND PRODUCT IN THIS COMPLAINT WAS PERFORMED. THIS COMPLAINT IS NOT IN SCOPE OF ANY ONGOING FIELD ACTIONS AND/OR CAPAS. BASED ON THE RESULTS THE REPORTED FAILURE "BOTH BATTERIES DEFECTIVE" COULD BE CONFIRMED. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED ISSUE AND IT WAS DETERMINED THAT THIS IS NOT A SYSTEMIC ISSUE. THEREFORE, NO REMEDIAL ACTION IS REQUIRED. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY'S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING.
IT WAS REPORTED THAT BOTH BATTERIES ARE DEFECTIVE AND THE CARDIOHELP DOES NOT FUNCTION UNLESS IT IS CONNECTED TO THE AC MAINS POWER. THE FAILURE OCCURRED DURING TREATMENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS BOTH BATTERIES WERE AFFECTED DURING TREATMENT, THE CARDIOHELP HAS NO BACKUP POWER SUPPLY. THEREFORE, A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).
COMPLAINT ID (B)(4) .
COMPLAINT ID # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1864448 | CARDIOHELP | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS | DTQ | MAQUET CARDIOPULMONARY GMBH | CARDIOHELP-I | 4037691658384 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |