FDA Adverse Event
Malfunction
Summary report: N
QUANTUM HEATER-COOLER MAIN UNIT
MDR report key: 24337747
·
Received February 13, 2026
Report
- Report Number
- 3006073153-2026-00026
- Event Type
- Malfunction
- Date Received
- February 13, 2026
- Date of Event
- January 15, 2026
- Report Date
- March 13, 2026
- Manufacturer
- SPECTRUM MEDICAL LTD
- Product Code
- DWC
- UDI-DI
- 05060434420961
- PMA / PMN Number
- K212657
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ROOT CAUSE DETERMINATION IS PENDING RESULTS OF INVESTIGATION.
Additional Manufacturer Narrative · 0
DURING INVESTIGATION, THE REPORTED FAULT WAS UNABLE TO BE CONFIRMED. IT IS SUSPECTED THAT PRESSURE BUILDUP WAS RELIEVED WHEN CONNECTED TO THE HEATER COOLER CHARGER AS INTENDED. AS PART OF PREVENTATIVE MAINTENANCE, SPECTRUM MEDICAL UPGRADED THE SOLENOID FIRMWARE AND CONFIRMED VIA FUNCTIONAL TESTING THAT THE UNIT WAS ABLE TO COOL TO THE SPECIFIED SETPOINT.
Description of Event or Problem · 0
USER REPORTED THAT THE DEVICE WAS UNABLE TO MEET SETPOINT WHEN TRYING TO COOL. THERE WAS NO PATIENT HARM.
Description of Event or Problem · 0
USER REPORTED THAT THE DEVICE WAS UNABLE TO MEET SETPOINT WHEN TRYING TO COOL. THERE WAS NO PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 401083 | QUANTUM HEATER-COOLER MAIN UNIT | TEMPERATURE CONTROLLER | DWC | SPECTRUM MEDICAL LTD | QHC1 | 05060434420961 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |