FDA Adverse Event
Malfunction
Summary report: N
CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V
MDR report key: 21570731
·
Received March 11, 2025
Report
- Report Number
- 2249723-2025-0001129
- Event Type
- Malfunction
- Date Received
- March 11, 2025
- Date of Event
- February 21, 2025
- Report Date
- March 28, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567107295
- PMA / PMN Number
- K031636
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TH
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DUE TO INITIAL CHARACTER LIMITATION, INITIAL REPORTER NAME: (B)(6). EVENT CITY: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
Additional Manufacturer Narrative · 0
UPDATED FIELDS: B4, G3, G6, H2, H11. AFTER FURTHER INVESTIGATION, IT WAS IDENTIFIED THAT THIS COMPLAINT EVENT IS NON-REPORTABLE IN US SO SHARING DOWNGRADED MDR. PLEASE CANCEL MFG REPORT NUMBER 2249723-2025-0001129 IN YOUR DATABASE."
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING PM CS100 CARDIOSAVE INTRA-AROTIC BALLOON PUMP (IABP) HAD SAFETY DISK DUE FOR REPLACEMENT. THERE WAS NO PATIENT INVOLVEMENT.
Description of Event or Problem · 0
NA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 337848 | CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0998-00-3013-55 | 10607567107295 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | NA. |