CARDIOSAVE HYBRID W/ E/F PLUG
Report
- Report Number
- 2249723-2024-03076
- Event Type
- Malfunction
- Date Received
- August 1, 2024
- Date of Event
- July 11, 2024
- Report Date
- January 10, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
UPDATED FIELDS: B4, D8, D9, G3, G6, H2, H3, H10 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSION), H11. IT WAS REPORTED BEFORE USE THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) COULD NOT BE SWITCHED ON. A MEDITEC MEDICAL ENGINEERING TEAM EVALUATED THE DEVICE AND CONFIRMED THE ISSUE. MEDITEC REPLACED THE POWER MANAGEMENT BOARD TO RESOLVE THE ISSUE AND SOFTWARE UPDATE TO VERSION D.01. AFTER THE REPAIR, MAINTENANCE AND STK WERE CARRIED OUT ACCORDING TO THE MANUFACTURER'S SPECIFICATIONS. MEDITEC CONFIRMED CALIBRATIONS, FUNCTION TEST AND TEST RUN OK. DEVICE IS READY FOR USE. THERE WAS NO PATIENT INVOLVEMENT.
IT WAS REPORTED THAT BEFORE USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) CAN NOT BE SWITCHED ON. THERE WAS NO PATIENT INVOLVEMENT.
IT WAS REPORTED THAT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) CAN NOT BE SWITCHED ON. THERE WERE NO KNOWN INJURIES.
N/A
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2066123 | 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 |