FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID, 3.1 EDITION
MDR report key: 21312970
·
Received February 5, 2025
Report
- Report Number
- 2249723-2025-0000537
- Event Type
- Malfunction
- Date Received
- February 5, 2025
- Date of Event
- March 14, 2024
- Report Date
- February 18, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567113432
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
(B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
Additional Manufacturer Narrative · 0
AFTER FURTHER REVIEW, IT HAS BEEN DETERMINED THAT AN INITIAL EMDR FOR THIS COMPLAINT WAS INCORRECTLY SUBMITTED. THE REASON BEING IS THAT THE REPORTED ISSUE OCCURRED AS PART OF AN EXPECTED INCOMING INSPECTION INTERNAL PROCESS, MAKING THIS ISSUE NON-REPORTABLE. CONSEQUENTLY, A FOLLOW UP EMDR IS NOT REQUIRED AS THIS CASE WAS REPORTED IN ERROR. PLEASE CANCEL MFG REPORT NUMBER 2249723-2025-0000537 IN YOUR DATABASE.
Description of Event or Problem · 0
IT WAS REPORTED DURING RECEIVING PROCESS IN THE WAREHOUSE THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HELIUM GAS LEAKAGE DETECTED. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Description of Event or Problem · 0
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 64750 | CARDIOSAVE HYBRID, 3.1 EDITION | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0998-00-0800-65 | 10607567113432 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |