FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID, TYPE B PLUG
MDR report key: 19756297
·
Received July 16, 2024
Report
- Report Number
- 2249723-2024-02857
- Event Type
- Malfunction
- Date Received
- July 16, 2024
- Date of Event
- June 24, 2024
- Report Date
- February 17, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
Additional Manufacturer Narrative · 0
A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND RESOLVED THE ISSUE BY REPLACING FIBER OPTIC ASSY D997-00-1169 AND D012-00-1808 CABLE, FIBER OPTIC JUMPER. FSE CALIBRATED AND THEN TESTED THE SAFETY AND FUNCTIONALITY AS PER FACTORY SPECIFICATIONS AND IABP WAS THEN RETURNED TO CUSTOMER FOR CLINICAL USE.
Description of Event or Problem · 0
IT WAS REPORTED THAT WHILE ON PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAS FIBER OPTIC SENSOR FAILURE ON THE SCREEN. UNIT NEVER STOPPED PUMPING. USERS SWAPPED OUT CONSOLE TO CONTINUE TREATMENT WITHOUT ISSUE. NO PATIENT HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 748988 | 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 |