CARDIOSAV HYBRID WITH E/F PLUG
Report
- Report Number
- 2249723-2022-01174
- Event Type
- Malfunction
- Date Received
- May 19, 2022
- Date of Event
- April 20, 2022
- Report Date
- February 18, 2023
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567108414
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
TYPE OF INVESTIGATION NOT YET DETERMINED: A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION.
"THE DOOPLER DEVICE IABP IS A SEPARATE DEVICE. THERE WAS NO REPORTED PROBLEM WITH THE OPERATION OF THE IABP. THE DOPPLER DEVICE WAS NOT A GETINGE PRODUCT, IT WAS FROM A DIFFERENT MANUFACTURER." COMPLAINT RECORD IS BEING CLOSED/CANCELLED AS THE INFORMATION RECEIVED DOES NOT MEET THE DEFINITION OF A COMPLAINT. CORRECTED ENTIRE SECTIONS TO BLANK: B, D, E, G, H UPDATED SECTIONS: B4, G3, G6, 2, H10, H11.
IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A NON WORKING DOPPLER. IT IS UNKNOWN UNDER WHICH CIRCUMSTANCES THE EVENT OCCURRED OR IF A PATIENT WAS INVOLVED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.
THE DOOPLER DEVICE IABP IS A SEPARATE DEVICE. THERE WAS NO REPORTED PROBLEM WITH THE OPERATION OF THE IABP. THE DOPPLER DEVICE WAS NOT A GETINGE PRODUCT, IT WAS FROM A DIFFERENT MANUFACTURER. COMPLAINT RECORD IS BEING CLOSED/CANCELLED AS THE INFORMATION RECEIVED DOES NOT MEET THE DEFINITION OF A COMPLAINT.
N/A
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2094789 | CARDIOSAV HYBRID WITH E/F PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. - MAHWAH | 0998-00-0800-55 | N/A | 10607567108414 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |