FDA Adverse Event
Malfunction
Summary report: N
QVM2-N-TM - QUANTUM VENTILATION MODULE
MDR report key: 24838563
·
Received April 10, 2026
Report
- Report Number
- 3006073153-2026-00106
- Event Type
- Malfunction
- Date Received
- April 10, 2026
- Date of Event
- January 8, 2026
- Report Date
- April 10, 2026
- Manufacturer
- SPECTRUM MEDICAL LTD.
- Product Code
- DTX
- UDI-DI
- 05060434422743
- PMA / PMN Number
- K202733
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
REPORT SUBMITTED FOLLOWING REVIEW OF WORLDWIDE COMPLAINTS DETERMINED THIS REPORT WAS MISSED FROM REPORTING TO THE FDA. NO PATIENT HEALTH AND SAFETY IMPACT OR DELAYS TO SURGERIES.
Description of Event or Problem · 0
USER REPORTED A PROBLEM WITH THE VAVD, THE SETPOINT IS NOT HOLD AND COME BACK TO 0. SPECTRUM EMPLOYEE WENT ON SITE TO TEST UNIT. THE QVM DOES NOT HOLD THE SETPOINT AND SHOW ERROR 600.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 481386 | QVM2-N-TM - QUANTUM VENTILATION MODULE | CARDIOPULMONARY BYPASS SYSTEM GAS CONTROL UNIT | DTX | SPECTRUM MEDICAL LTD. | QVM2-N-TM | 05060434422743 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |