FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID, TYPE G PLUG
MDR report key: 20326136
·
Received September 27, 2024
Report
- Report Number
- 2249723-2024-0003962
- Event Type
- Malfunction
- Date Received
- September 27, 2024
- Report Date
- October 2, 2024
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108438
- PMA / PMN Number
- K112372
- Report Source
- Manufacturer report
- Reporter Location
- EI
- 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
COMPLAINT RECORD BEING CANCELLED AS IT IS A DUPLICATE TO TW# (B)(4); MFG REPORT NUMBER 2249723-2024-03354. REVERT ALL SECTIONS TO BLANK: B. ADVERSE EVENT OR PRODUCT PROBLEM D. SUSPECT MEDICAL DEVICE E. INITIAL REPORTER G. ALL MANUFACTURERS H. DEVICE MANUFACTURERS ONLY.
Description of Event or Problem · 0
IT WAS REPORTED THAT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNITS EXTERNAL ECG SYNC IS NOT WORKING.
Description of Event or Problem · 0
COMPLAINT RECORD BEING CANCELLED AS IT IS A DUPLICATE TO TW# (B)(4); MFG REPORT NUMBER 2249723-2024-03354.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1504199 | 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 |