CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
Report
- Report Number
- 2249723-2023-01812
- Event Type
- Malfunction
- Date Received
- April 7, 2023
- Date of Event
- March 28, 2023
- Report Date
- August 25, 2023
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567107882
- PMA / PMN Number
- K063525
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- 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 INVESTIGATE THE ISSUE. IN ORDER TO FIX THE ISSUE, THE FSE REPLACED THE BROKEN HANDLE. THE UNIT THEN PASSED ALL CALIBRATION, FUNCTIONAL AND SAFETY TESTS PERFORMED, AND THE UNIT WAS RETURNED TO CUSTOMER AND CLEARED FOR CLINICAL USE. THE REMOVED PARTS WERE RETURNED TO FAILURE ANALYSIS AND TESTING FOR EVALUATION. THE FAILURE ANALYSIS AND TESTING DEPT.(FAT) RECEIVED PARTS 0367-00-0090 CART HANDLE AND 0216-02-1016 SCREW,PAN HEAD. THESE PARTS WERE RECEIVED WITH A REPORTED UNIT FAILURE OF THE CART HANDLE BEING BROKEN. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION AND FOUND THE CART HANDLE BROKEN. RETAINING THE CART HANDLE IN THE FAT DEPT. PER PROCEDURE.
IT WAS REPORTED THAT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNITS HANDLE IS BROKEN AFTER TIPPING OVER.
N/A
IT WAS REPORTED THAT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNITS HANDLE IS BROKEN AFTER TIPPING OVER. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 550293 | CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. - MAHWAH | 0998-00-3023-53 | 10607567107882 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |