FDA Adverse Event
Malfunction
Summary report: N
CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
MDR report key: 24828895
·
Received April 9, 2026
Report
- Report Number
- 2249723-2026-0002129
- Event Type
- Malfunction
- Date Received
- April 9, 2026
- Date of Event
- March 18, 2026
- Report Date
- April 16, 2026
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567107882
- PMA / PMN Number
- K063525
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
UPDATED DATA: B4, G3, G6, H1, H2, H11. CORRECTED DATA: D5, D8.
Additional Manufacturer Narrative · 0
A GETINGE FIELD SERVICE ENGINEER (FSE) WAS EVALUATED THE UNIT. THE FSE REPORTED THAT THE YOKE EXTENDER (0103-00-0538) WAS BENT. IT WAS NOTED THAT THE PHYSICAL DAMAGE WAS DUE TO CUSTOMER ABUSE. THE COMPONENT WAS REPLACED. DEVICE PASSED THE PERFORMANCE AND SAFETY CHECKS ACCORDING TO FACTORY SPECIFICATIONS.
Description of Event or Problem · 0
N/A.
Description of Event or Problem · 0
IT WAS REPORTED BY FSE THAT IN CS300 INTRA AORTIC BALLOON PUMP(IABP) HELIUM TANK YOKE EXTENDER FOUND BENT DURING PREVENTIVE MAINTENANCE. THERE WAS NO PATIENT INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 6969 | 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 |