FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID, TYPE B PLUG
MDR report key: 21856002
·
Received April 17, 2025
Report
- Report Number
- 2249723-2025-0001822
- Event Type
- Malfunction
- Date Received
- April 17, 2025
- Date of Event
- April 3, 2025
- Report Date
- September 18, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
UPDATED FIELDS: B4, G1 (CONTACT PERSON ¿ MFG SITE), G3, G6, H2, H11. UPON FURTHER REVIEW AND INVESTIGATION, IT WAS IDENTIFIED THAT THIS COMPLAINT EVENT HAS BEEN REPORTED ALREADY UNDER MFG REPORT NUMBER 2249723-2025-0001801. PLEASE REFER TO MFG REPORT NUMBER 2249723-2025-0001801 FOR ALL INFORMATION FOR THIS COMPLAINT EVENT. PLEASE CANCEL IN YOUR DATABASE.
Additional Manufacturer Narrative · 0
SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
Description of Event or Problem · 0
IT WAS REPORTED THAT CARDIOSAVE INTRA AORTIC BALLOON PUMP(IABP). THERE WAS NO PATIENT INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1748117 | CARDIOSAVE HYBRID, TYPE B PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0998-00-0800-53 | 10607567108391 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | N/A. |