FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID, TYPE B PLUG
MDR report key: 21363556
·
Received February 12, 2025
Report
- Report Number
- 2249723-2025-0000655
- Event Type
- Malfunction
- Date Received
- February 12, 2025
- Date of Event
- January 24, 2025
- Report Date
- April 8, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
UPDATED FIELD: B4, G3, G6, H2, H11. AFTER FURTHER INVESTIGATION, IT WAS IDENTIFIED THAT THIS COMPLAINT EVENT HAS BEEN REPORTED ALREADY UNDER MFG REPORT NUMBER 2249723-2025-0000597. PLEASE REFER TO MFG REPORT NUMBER 2249723-2025-0000597 FOR ALL INFORMATION FOR THIS COMPLAINT EVENT. PLEASE CANCEL MFG REPORT NUMBER 2249723-2025-0000655 IN YOUR DATABASE.
Additional Manufacturer Narrative · 0
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.
Description of Event or Problem · 0
IT WAS REPORTED THAT CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP) WAS ON A PATIENT AND HAD A DEFLATED IAB HELIUM TRANSDUCER CALIBRATION NEEDED. THERE WAS NO PATIENT HARM REPORTED
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1042082 | 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 |