FDA Adverse Event
Malfunction
Summary report: N
CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V
MDR report key: 23002914
·
Received September 9, 2025
Report
- Report Number
- 2249723-2025-0003762
- Event Type
- Malfunction
- Date Received
- September 9, 2025
- Date of Event
- August 19, 2025
- Report Date
- October 23, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567112541
- PMA / PMN Number
- K063525
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DUE TO CHARACTER LIMIT IN E1 FULL EVENT SITE NAME: (B)(6) HOSPITAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
Additional Manufacturer Narrative · 0
UPDATED FIELDS: B4, B5, G3, G6, H2, H3, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE AND REPLACED BATTERIES AND UNIT PASSED. BATTERIES ARE CHARGED TO THE NUH PM CONTRACT REPLACEMENT.
Description of Event or Problem · 0
IT WAS REPORTED BEFORE USE THAT A CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD AUTO SHUT DOWN. THERE WAS NO PATIENT INVOLVED.
Description of Event or Problem · 0
IT WAS REPORTED BEFORE USE THAT A CS300 INTRA-AORTIC BALLOON PUMP (IABP) BATTERIES CANNOT LAST AND CAUSING THE AUTO SHUTDOWN. THERE WAS NO PATIENT INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1916019 | CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0998-00-3023-55 | 10607567112541 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |