CARDIOSAVE HYBRID, TYPE G PLUG
Report
- Report Number
- 2249723-2024-02146
- Event Type
- Malfunction
- Date Received
- May 23, 2024
- Date of Event
- May 15, 2024
- Report Date
- February 6, 2025
- 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
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE IABP AND THE FSE CONSULTED FACTORY ON BROKEN CHIP ON BACKPLANE. U1 CHIP CONTROLS THE DEVICE ID AND LISTS THE SERIAL NUMBER OF EACH BOARD IN THE DIAGNOSTICS MODE. THE FSE REPLACED BACKPLANE AND PERFORM SYSTEM FUNCTIONAL CHECK. UNIT TESTED PASS IAW FACTORY SPEC AND UNIT HANDED TO USER. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0670-00-1163 REV. A, SN (B)(6) SWEMCO WITH A REPORTED UNIT FAILURE OF A BROKEN U1 CHIP. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO HAVE PHYSICAL DAMAGE AND BE MISSING THE U1 CHIP. FAILURE IS CONFIRMED BUT NO ROOT CAUSE IDENTIFIED. RETAINING THE PARTS IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE.
UDI RELATED DATA QUALITY UPDATES ONLY. PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID (D1, D2, D3, D4, G4, H4, H5).
IT WAS REPORTED THAT BEFORE USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) BACKPLANE IS FAULTY. THERE WAS NO PATIENT INVOLVEMENT REPORTED .
N/A
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 502066 | 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 |