FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID, TYPE I PLUG
MDR report key: 21882468
·
Received April 22, 2025
Report
- Report Number
- 2249723-2025-0001902
- Event Type
- Malfunction
- Date Received
- April 22, 2025
- Date of Event
- April 10, 2025
- Report Date
- December 3, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108421
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DUE TO CHARACTER RESTRICTIONS IN BLOCK E1 FULL INITIAL REPORTER NAME IS (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.
Additional Manufacturer Narrative · 0
THE INCIDENT WAS DETERMINED TO BE A DUPLICATE REPORT TO COMPLAINT (B)(4) (MFG REPORT NUMBER 2249723-2025-0001903). AS A RESULT, NO FOLLOW UP EMDR IS NECESSARY. PLEASE CANCEL THIS IN YOUR DATABASE.
Description of Event or Problem · 0
IT WAS REPORTED THAT CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP) TOUCHSCREEN WAS NOT RESPONDING. THERE WAS NO HARM OR INJURY REPORTED TO THE PATIENT.
Description of Event or Problem · 0
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1015467 | CARDIOSAVE HYBRID, TYPE I PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0998-00-0800-45 | 10607567108421 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Male |