FDA Adverse Event
Malfunction
Summary report: N
CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
MDR report key: 17812395
·
Received September 25, 2023
Report
- Report Number
- 2249723-2023-04168
- Event Type
- Malfunction
- Date Received
- September 25, 2023
- Date of Event
- September 14, 2023
- Report Date
- January 25, 2024
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567107882
- PMA / PMN Number
- K063525
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE FSE (FIELD SERVICE ENGINEER) STATED THAT THE ECG CONNECTOR WAS BROKEN DUE TO CUSTOMER NEGLIGENCE. THE FSE REPLACED THE ECG INPUT TO FRONT END CBL ASSY (0012-00-0976). THE FSE THEN COMPLETED CHECKOUT AND CHECKLIST. THE UNIT PASSED ALL FUNCTIONAL TESTING.
Additional Manufacturer Narrative · 0
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
Description of Event or Problem · 0
N/A
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) ,THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNITS ECG CONNECTOR WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1241514 | 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 |