FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID, 3.1 EDITION
MDR report key: 21822907
·
Received April 11, 2025
Report
- Report Number
- 2249723-2025-0001709
- Event Type
- Malfunction
- Date Received
- April 11, 2025
- Date of Event
- March 31, 2025
- Report Date
- September 8, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
Additional Manufacturer Narrative · 0
AFTER FURTHER REVIEW, AN INITIAL EMDR FOR THIS COMPLAINT WAS INCORRECTLY SUBMITTED. THE INCIDENT WAS DETERMINED TO BE A DUPLICATE REPORT TO COMPLAINT TW (B)(4) (AUTHORITY REF 2249723-2025-0001760. AS A RESULT, NO FOLLOW UP EMDR IS NECESSARY. PLEASE CANCEL IN YOUR DATABASE.
Description of Event or Problem · 0
IT WAS REPORTED THAT CARDIOSAVE IABP (INTRA-AORTIC BALLOON PUMP) HAD FREQUENT AUTOMATIC FILLING ERRORS.
Description of Event or Problem · 0
NA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2340534 | CARDIOSAVE HYBRID, 3.1 EDITION | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0998-00-0800-65 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | UNKNOWN. |