CARDIOHELP
Report
- Report Number
- 8010762-2026-0000217
- Event Type
- Malfunction
- Date Received
- May 18, 2026
- Date of Event
- April 24, 2026
- Report Date
- May 7, 2026
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTQ
- UDI-DI
- 4037691658384
- PMA / PMN Number
- K133598
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- 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. THIS EVENT OCCURRED ON THE SPAIN 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.
THE EVENT OCCURRED IN SPAIN, AFTER TRANSPORT OF A PATIENT. IT WAS REPORTED THAT THERE IS A BATTERY PROBLEM. THE CARDIOHELP WAS USED FOR TRANSPORT TO ANOTHER HOSPITAL AND WHEN THE DEVICE WAS RETURNED, A BATTERY CALIBRATION WAS NEEDED. BOTH BATTERIES WERE AFFECTED. THE BATTERY LEVELS WERE 83% AND 82%. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS BOTH BATTERIES WERE AFFECTED, THERE IS NO BACK-UP POWER SUPPLY IN THE EVENT OF AC POWER FAILURE DURING TREATMENT. THEREFORE, A REPORT IS REQUIRED. COMPLAINT ID (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 23849 | CARDIOHELP | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS | DTQ | MAQUET CARDIOPULMONARY GMBH | CARDIOHELP-I | 4037691658384 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |