CARDIOSAVE HYBRID, TYPE B PLUG
Report
- Report Number
- 2249723-2023-05440
- Event Type
- Malfunction
- Date Received
- December 22, 2023
- Date of Event
- December 15, 2023
- Report Date
- September 23, 2024
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND RESOLVED THE ISSUE BY REPLACING DISPLAY TOP LCD ROHS , 2 HINGE,DISPLAY,RIGHT , DISPLAY,UPPER HINGE COVER AND LABELING ASSOCIATED WITH SCREEN REPLACEMENT. FSE THEN TESTED THE SAFETY AND FUNCTIONALITY AS PER FACTORY SPECIFICATIONS AND IABP WAS THEN RETURNED TO CUSTOMER FOR CLINICAL USE. THE DEFECTIVE COMPONENTS WERE RECEIVED FOR FURTHER INVESTIGATION. PLEASE REFER TO THE ROOT CAUSE EVALUATION FIELD FOR DETAILS. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER: 0105-00-0138-02 SERIAL NUMBER: N/A WITH A REPORTED UNIT FAILURE OF A DAMAGED DISPLAY RIGHT HINGE. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED VISUAL INSPECTION OF THE RECEIVED PART : DISPLAY RIGHT HINGE P/N: 0105-00-0138-02 SERIAL NUMBER: N/A AND FOUND THAT IT IS DAMAGED. DUE TO THIS DAMAGE. THIS PART CANNOT BE INVESTIGATED ANY FURTHER BY THE FAILURE ANALYSIS AND TESTING DEPARTMENT. THE FAILURE ANALYSIS AND TESTING DEPARTMENT VERIFIED THE DAMAGED DISPLAY RIGHT HINGE. RETAINING THE PART IN THE FAT DEPT. PER PROCEDURE 0002-07-D008 REV. AQ. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS IMPOSSIBLE TO BE DEFINED.
UPDATED DATA: B4, E1 (EMAIL), G3, G6, H2, H10.
**UDI RELATED DATA QUALITY UPDATES ONLY** PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID (D1, D2, D3, D4, G4, H4, H5)
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
N/A.
N/A
N/A
IT WAS REPORTED THAT , THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNITS MONITOR IS DAMAGED. IT IS MISSING THE DISPLAY HINGE COVERS. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 289014 | CARDIOSAVE HYBRID, TYPE B PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0998-00-0800-53 | 10607567108391 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |