CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
Report
- Report Number
- 2249723-2026-0001636
- Event Type
- Malfunction
- Date Received
- March 12, 2026
- Date of Event
- February 18, 2026
- Report Date
- March 26, 2026
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567107882
- PMA / PMN Number
- K063525
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
AFTER FURTHER INVESTIGATION, IT WAS IDENTIFIED THAT THIS COMPLAINT EVENT IS A DUPLICATE OF COMPLAINT EVENT MFG REPORT NUMBER: 2249723 2025 0003751. PLEASE REFER TO MFG REPORT NUMBER: 2249723 2025 0003751 FOR ALL INFORMATION FOR THIS COMPLAINT EVENT. PLEASE CANCEL MFG REPORT NUMBER: 2249723 2026 0001636 IN YOUR DATABASE.
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
AFTER FURTHER INVESTIGATION, IT WAS IDENTIFIED THAT THIS COMPLAINT EVENT IS A DUPLICATE OF COMPLAINT EVENT MFG REPORT NUMBER: 2249723 2025 0003751. PLEASE REFER TO MFG REPORT NUMBER: 2249723 2025 0003751 FOR ALL INFORMATION FOR THIS COMPLAINT EVENT. PLEASE CANCEL MFG REPORT NUMBER: 2249723 2026 0001636 IN YOUR DATABASE.
IT WAS REPORTED DURING USE THAT THE CS300 IABP DISPLAY SCREEN WAS FLICKERING. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 638575 | CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0998-00-3023-53 | 10607567107882 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | N/A. |