CARDIOSAVE HYBRID, TYPE B PLUG
Report
- Report Number
- 2249723-2026-0001928
- Event Type
- Malfunction
- Date Received
- March 30, 2026
- Date of Event
- March 9, 2026
- Report Date
- April 17, 2026
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
OTHER CONTACT PHONE NUMBER: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
AFTER FURTHER REVIEW, AN INITIAL EMDR FOR THIS COMPLAINT WAS INCORRECTLY SUBMITTED. IN THIS COMPLAINT ALARMING, GAS LOSS AND IABP CIRCUIT. FSE INSPECTED THE UNIT AND COULD NOT DUPLICATE THE ISSUE MAKING IT NON REPORTABLE TO THE FDA. AS A RESULT, NO FOLLOW UP EMDR IS NECESSARY. PLEASE CANCEL 2249723 2026 0001928 IN YOU DATABASE.
IT WAS REPORTED BY THE CUSTOMER THAT DURING USE THE CARDIOSAVE IABP WAS ALARMING, GAS LOSS. THERE WAS NO PATIENT HARM OR INJURY REPORTED.
AFTER FURTHER REVIEW, AN INITIAL EMDR FOR THIS COMPLAINT WAS INCORRECTLY SUBMITTED. IN THIS COMPLAINT ALARMING, GAS LOSS AND IABP CIRCUIT. FSE INSPECTED THE UNIT AND COULD NOT DUPLICATE THE ISSUE MAKING IT NON REPORTABLE TO THE FDA. AS A RESULT, NO FOLLOW UP EMDR IS NECESSARY. PLEASE CANCEL 2249723 2026 0001928 IN YOU DATABASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 785505 | 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 |