FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID, TYPE B PLUG
MDR report key: 20961691
·
Received December 18, 2024
Report
- Report Number
- 2249723-2024-0005093
- Event Type
- Malfunction
- Date Received
- December 18, 2024
- Date of Event
- November 25, 2024
- Report Date
- April 21, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
UPDATED FIELDS: B4, G1, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) REPORTED THAT THEY REPLACED THE FIBER OPTIC PORT (0012-00-1562). THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS AND WAS RETURNED TO CUSTOMER.
Additional Manufacturer Narrative · 0
UPDATED FIELDS: B4, G3, G4 (PMA/510K) G6, H2, H11.
Additional Manufacturer Narrative · 0
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
Description of Event or Problem · 0
N/A
Description of Event or Problem · 0
N/A.
Description of Event or Problem · 0
IT WAS REPORTED DURING PREVENTIVE MAINTENANCE THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A BROKEN FO PORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1720507 | CARDIOSAVE HYBRID, TYPE B PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0998-00-0800-53 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |