FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID W/ E/F PLUG
MDR report key: 19844788
·
Received July 26, 2024
Report
- Report Number
- 2249723-2024-03003
- Event Type
- Malfunction
- Date Received
- July 26, 2024
- Date of Event
- July 9, 2024
- Report Date
- September 12, 2024
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS BEING CANCELLED AS A DUPLICATE OF ONETRACK 1092217/ MFG REPORT NUMBER 2249723-2024-03353.
Additional Manufacturer Narrative · 0
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
Description of Event or Problem · 0
THIS REPORT IS BEING CANCELLED AS A DUPLICATE OF ONETRACK 1092217/ MFG REPORT NUMBER 2249723-2024-03353.
Description of Event or Problem · 0
IT WAS REPORTED THAT WHILE THE DEVICE WAS NOT IN USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS LEAKING HELIUM, THE BOTTLE WAS EMPTY. THERE WAS NO PATIENT INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1587528 | CARDIOSAVE HYBRID W/ E/F PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0998-00-0800-55 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |