FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID W/ E/F PLUG
MDR report key: 21854524
·
Received April 17, 2025
Report
- Report Number
- 2249723-2025-0001829
- Event Type
- Malfunction
- Date Received
- April 17, 2025
- Date of Event
- April 4, 2025
- Report Date
- May 29, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108414
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
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 COMPLAINT WAS CREATED IN ERROR, THERE WAS NO REPORTED CUSTOMER DISSATISFACTION RELATED TO THIS EVENT, MAKING IT NON-REPORTABLE TO THE FDA. AS A RESULT, NO FOLLOW UP EMDR IS NECESSARY. PLEASE CANCEL 2249723-2025-0001829 IN YOUR DATABASE.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) THE ALERT APPEARS ON THE HOME SCREEN AS BATTERY MAINTENANCE REQUIRED BAYS 1 AND 2.
Description of Event or Problem · 0
THE EVENT IS NOT REPORTABLE AS THERE WAS NO FAULT WITH THE DEVICE AND IT WAS JUST THE MESSAGE THE DEVICE DISPLAYS TO CHECK THE BATTERIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1732831 | CARDIOSAVE HYBRID W/ E/F PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0998-00-0800-55 | 10607567108414 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |