FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID, TYPE B PLUG
MDR report key: 24232940
·
Received February 2, 2026
Report
- Report Number
- 2249723-2026-0001029
- Event Type
- Malfunction
- Date Received
- February 2, 2026
- Date of Event
- January 7, 2026
- Report Date
- February 24, 2026
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
UPON FURTHER REVIEW IT WAS DETERMINED THAT THE REPORTED EVENT INVOLVED ONLY CONSOLE DAMAGE. THERE WAS NO ANY OTHER MALFUNCTION OF THE DEVICE AND THEREFORE THE EVENT DOES NOT MEET THE DEFINITION OF AN INCIDENT/SERIOUS INCIDENT, MAKING IT NON-REPORTABLE TO THE FDA. AS A RESULT, NO FOLLOW UP EMDR IS NECESSARY. PLEASE CANCEL MEDWATCH REPORT NUMBER- 2249723-2026-0001029 IN YOUR DATABASE.
Additional Manufacturer Narrative · 0
DUE TO CHARACTER LIMIT: E1 (EVENT SITE NAME)-(B)(6) HOSPITAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
Description of Event or Problem · 0
N/A
Description of Event or Problem · 0
IT WAS REPORTED THAT A CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS DAMAGED AFTER FALLING FROM A STRETCHER DURING RETURN FROM PATIENT TRANSPORT. NO PATIENT INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 293656 | 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 |