CARDIOSAVE HYBRID, TYPE G PLUG
Report
- Report Number
- 2249723-2023-04926
- Event Type
- Malfunction
- Date Received
- November 17, 2023
- Date of Event
- November 9, 2023
- Report Date
- September 20, 2024
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108438
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
EVENT SITE STATE AND POSTAL CODE: (B)(6). IT WAS REPORTED THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) NETWORK CONNECTIVITY TEST FOR D.00. A GETINGE FIELD SERVICE ENGINEER EVALUATED AFTER THE D.00 UPGRADE, THE NETWORK EXPORT SETTINGS WERE RESET AND THE CARDIOSAVE IS UNABLE TO EXPORT DATA TO THE PHILIPS INTELLIVUE EC10 AND EPIC EMR SYSTEM. ADJUSTED THE SETTINGS AND UNIT TESTED TO BE OK. NO PATIENT INVOLVEMENT.
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
**UDI RELATED DATA QUALITY UPDATES ONLY** PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID.
IT WAS REPORTED THAT DURING AFTER THE FSCA D.00 UPDATE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT'S NETWORK SETTINGS WERE RESET AND HAVE TO BE READJUSTED FOR IT TO CONNECT TO THE PHILIPS INTELLIVUE MONITORING SYSTEM AND EPIC EMR SYSTEM. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
IT WAS REPORTED THAT DURING AFTER THE FSCA D.00 UPDATE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT'S NETWORK SETTINGS WERE RESET AND HAVE TO BE READJUSTED FOR IT TO CONNECT TO THE PHILIPS INTELLIVUE MONITORING SYSTEM AND EPIC EMR SYSTEM.
N/A.
N/A
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1745301 | 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 |