FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID, TYPE B PLUG
MDR report key: 16409657
·
Received February 21, 2023
Report
- Report Number
- 2249723-2023-01183
- Event Type
- Malfunction
- Date Received
- February 21, 2023
- Date of Event
- February 9, 2023
- Report Date
- February 19, 2024
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
Additional Manufacturer Narrative · 0
THE GETINGE FIELD SERVICE ENGINEER (FSE) THAT ENCOUNTERED THE REPORTED ISSUE DURING THE INSTALLATION. ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER WITH REGARD TO THE REPAIR AND STATUS OF THE IABP; HOWEVER, DESPITE OUR BEST EFFORTS, NO REPAIR INFORMATION AND NO STATUS OF THE IABP HAS BEEN RECEIVED. IF ANY PERTINENT INFORMATION IS RECEIVED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. H3 OTHER TEXT : CUSTOMER HAVE NOT PROVIDED ANY INFORMATION.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING INSTALL, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT IS NOT PASSING SAFETY DISK TEST. THERE WAS NO PATIENT INVOLVEMENT.
Description of Event or Problem · 0
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1644149 | CARDIOSAVE HYBRID, TYPE B PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. - MAHWAH | 0998-00-0800-53 | 10607567108391 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |