FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID, TYPE B PLUG
MDR report key: 17939169
·
Received October 16, 2023
Report
- Report Number
- 2249723-2023-04451
- Event Type
- Malfunction
- Date Received
- October 16, 2023
- Date of Event
- October 5, 2023
- Report Date
- August 30, 2024
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
Additional Manufacturer Narrative · 0
**UDI RELATED DATA QUALITY UPDATES ONLY** PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID (D1, D2, D3, D4, G4, H4, H5).
Additional Manufacturer Narrative · 0
THE GETINGE FIELD SERVICE ENGINEER(FSE) THAT ENCOUNTERED THE ISSUE REPLACED DOPPLER ULTRASONIC IABP ASSEMBLY (0154-01-0596), TETHER ASSEMBLY (0997-00-0596), AND THE CLAMP BLOCK TETHER (0343-00-0084). THE FSE COMPLETED THE PM TO FACTORY SPECIFICATIONS. THE IABP WAS RETURNED TO THE CUSTOMER.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) , THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNITS DOPPLER IS MISSING. THERE WAS NO PATIENT INVOLVEMENT.
Description of Event or Problem · 0
N/A
Description of Event or Problem · 0
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1286244 | 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 |