CS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 110V
Report
- Report Number
- 2249723-2023-01625
- Event Type
- Malfunction
- Date Received
- March 27, 2023
- Date of Event
- March 16, 2023
- Report Date
- April 2, 2024
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567108308
- PMA / PMN Number
- K063525
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
UPDATED DATA: B4,G3,G6,H2,H10,H11. CORRECTED DATA: B5,B6,B7,D10,E3,H6(CLINICAL & IMPACT).
UPDATED FIELDS: B4, G3, G6, H2, H4, H6, H10.
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
ADDITIONAL INFORMATION: TEL - (B)(6). IT WAS BEING REPORTED THAT DURING A ROUTINE CHECK THE CS300 INTRA AORTIC BALLOON PUMP (IABP) HAD AN ISSUE REGARDING THE "HELIUM LEAK" . A GETINGE FIELD SERVICE ENGINEER (FSE) HAD COMMENTED THAT THE THERE WAS A FOLLOW-UP CALL FOR HELIUM LEAK ON THE SHELL SIDE. SHELL ATTACHMENT CHECK: RAS SEAL CHECK: NO FAULT LEAK CHECK IN DIAGNOSTIC MODE: NO LOSS OVER 5 MINUTES. MONITORING AGREEMENT BY THE BIOMEDICAL SERVICE OVER SEVERAL DAYS FBC 3395. THERE WAS NO INVOLVEMENT OF THE PATIENT.
IT WAS REPORTED THAT DURING USER CHECK THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) BOTTLE LEAKED. THERE WAS NO PATIENT INVOLVEMENT.
N/A.
IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) BOTTLE LEAKED.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 739939 | CS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 110V | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. - MAHWAH | 0998-00-3023-62 | 10607567108308 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | N/A.| UNKNOWN. |