FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID, TYPE G PLUG
MDR report key: 21046021
·
Received December 31, 2024
Report
- Report Number
- 2249723-2024-0005348
- Event Type
- Malfunction
- Date Received
- December 31, 2024
- Date of Event
- December 9, 2024
- Report Date
- January 31, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108438
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE FSE CHECK LOG FILES, UNIT LAST POWER UP WAS ON (B)(6) 2024 NO OVERHEATING LOG FILES OCCURED ON THIS UNIT. PERFORMED SYSTEM FUNCTIONAL CHECK AND RUN ON CLINICAL MODE. RESULT TESTED PASS IAW FACTORY SPECIFICATIONS UNIT HANDED TO USER.
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION: EVENT SITE TELEPHONE: (B)(6). 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 BEFORE USE, CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS OVERHEATED. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1847228 | CARDIOSAVE HYBRID, TYPE G PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0998-00-0800-52 | 10607567108438 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |