FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID, TYPE B PLUG
MDR report key: 21155716
·
Received January 15, 2025
Report
- Report Number
- 2249723-2025-0000208
- Event Type
- Malfunction
- Date Received
- January 15, 2025
- Date of Event
- December 28, 2024
- Report Date
- February 12, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
AFTER FURTHER INVESTIGATION, IT WAS IDENTIFIED THAT THIS COMPLAINT EVENT HAS BEEN REPORTED ALREADY UNDER MFG REPORT NUMBER 2249723-2025-0000242. PLEASE REFER TO MFG REPORT NUMBER 2249723-2025-0000242 FOR ALL INFORMATION FOR THIS COMPLAINT EVENT. PLEASE CANCEL IN YOUR DATABASE.
Additional Manufacturer Narrative · 0
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING SET UP OF UNIT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WOULD NOT COMPLETE THE INITIAL START UP AND WAS STUCK IN THE ROTATING START UP SCREEN. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1364269 | 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 |