CARDIOSAVE HYBRID, TYPE B PLUG
Report
- Report Number
- 2249723-2023-05054
- Event Type
- Malfunction
- Date Received
- November 28, 2023
- Date of Event
- November 17, 2023
- Report Date
- September 27, 2024
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
A GETINGE FIELD SERVICE ENGINEER (FSE) CONFIRMED THE REPORTED ISSUE. THE FSE REPLACED ALL REQUIRED PARTS AND COMPLETED ALL CHECKOUTS WITH NO ISSUES. THE UNIT WAS APPROVED FOR CLINICAL USE AND RETURNED TO THE DEPARTMENT. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PART NUMBER 0105-00-0138-02, PN 0380-00-0561 (QTY:2), PN 0380-00-0560, PN 0380-00-0559. THESE PARTS WERE RECEIVED WITH A REPORTED FAILURE OF PHYSICAL DAMAGE ON EACH PART. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PARTS TO HAVE PHYSICAL DAMAGE. VERIFIED THE REPORTED ISSUE BUT NO ROOT CAUSE ABLE TO BE DEFINED. RETAINING THE PARTS IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE.
FIRM PROVIDED UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID.
IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) DISPLAY DROPPED AND MULTIPLE PARTS BROKE. THERE WAS NO PATIENT INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 532252 | 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 |