FDA Adverse Event
Malfunction
Summary report: N
CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V
MDR report key: 17059346
·
Received June 5, 2023
Report
- Report Number
- 2249723-2023-02663
- Event Type
- Malfunction
- Date Received
- June 5, 2023
- Date of Event
- May 25, 2023
- Report Date
- February 28, 2024
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567107295
- PMA / PMN Number
- K031636
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TH
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
Additional Manufacturer Narrative · 0
A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE IABP UNIT AND WAS ABLE TO REPRODUCE THE REPORTED ISSUE. TO FIX THE ISSUE, THE FSE REPLACED PART: CBL ASSY BP INPUT TO FRONT END (0012-00-0977), AND PERFORMED ALL FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS. UNIT PASSED ALL FUNCTIONAL AND SAFETY TEST PER FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED AND CLEARED FOR CLINICAL SERVICE.
Description of Event or Problem · 0
IT WAS REPORTED THAT BEFORE USE THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) CAN'T SET TO ZERO. THERE WAS NO PATIENT INVOLVEMENT REPORTED .
Description of Event or Problem · 0
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29817 | CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. - MAHWAH | 0998-00-3013-55 | 10607567107295 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |