CARDIOSAVE HYBRID, TYPE B PLUG
Report
- Report Number
- 2249723-2023-00591
- Event Type
- Malfunction
- Date Received
- January 27, 2023
- Report Date
- March 4, 2024
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA
- Reporter Occupation
- 003
Narratives
A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE IABP UNIT FOR THE REPORTED BROKEN HINGE LOCATED BETWEEN THE MONITOR AND THE TOUCH SCREEN PANEL. THE FSE STATED THAT THE RIGHT HINGE WAS BROKEN AND REPLACED THE RIGHT DISPLAY HINGE (0105-00-0138-02) AND THE HINGE COVER (0380-00-0561). DURING THE REPAIR, THE LEFT HINGE BROKE. THE FSE ORDERED THE PART AND RETURNED TO REPLACE THE LEFT DISPLAY HINGE (0105-00-0138-01) ON THE MONITOR. THE FSE VERIFIED THAT THE UNIT WAS CALIBRATED. THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE.
A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. THIS REPORT IS BEING SUBMITTED AS THE RESULT OF A RETROSPECTIVE REVIEW CONDUCTED IN CAPA (B)(4).
N/A.
IT WAS REPORTED THAT DURING A ROUTINE CHECK THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD THE LEFT HINGE ON THE MONITOR THAT WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 412783 | CARDIOSAVE HYBRID, TYPE B PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. - MAHWAH | 0998-00-0800-53 | 10607567108391 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |