FDA Adverse Event
Malfunction
Summary report: N
CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V
MDR report key: 16490011
·
Received March 6, 2023
Report
- Report Number
- 2249723-2023-01387
- Event Type
- Malfunction
- Date Received
- March 6, 2023
- Date of Event
- February 24, 2023
- Report Date
- March 1, 2024
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567107790
- PMA / PMN Number
- K031636
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
INITIAL REPORTER INFO: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
Additional Manufacturer Narrative · 0
A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND FOUND THAT THE EQUIPMENT MOTOR NEEDS TO BE REPLACED WITH A MAINTENANCE KIT, THE DRIVE VALVE GROUP ALSO LEAKS AIR AND NEEDED TO BE REPLACED. FSE REPLACED MANIFOLD DRIVE (D104-00-0018) AND KIT 5000 HR PREVENT MAINT (D040-00-0147). ALL FUNCTIONAL AND SAFETY CHECKS PERFORMED TO MEET FACTORY SPECIFICATIONS AND UNIT CLEARED FOR CLINICAL USE.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING START UP TESTING, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD AN INFLATION FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Description of Event or Problem · 0
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1594533 | CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. - MAHWAH | 0998-00-3013-45 | 10607567107790 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | N/A. |