CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V
Report
- Report Number
- 2249723-2025-0000346
- Event Type
- Malfunction
- Date Received
- January 28, 2025
- Date of Event
- January 7, 2025
- Report Date
- October 31, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567107295
- PMA / PMN Number
- K031636
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
UPDATED FIELDS: B4, G3, G6, H2, H6 (HEALTH EFFECT ¿ CLINICAL CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) CHECKED THE MACHINE AND FOUND DISPLAY WAS FLICKERING AND BEGAN BY CHECKING AND RECONNECTING THE DISPLAY CABLES BUT THAT DID NOT RESOLVE THE ISSUE. REPLACEMENT OF THE CABLE, DISPLAY TO VIDEO RCVR BD (0012-00-1429) RESOLVED THE FLICKERING ERROR AND RETURNED THE DEVICE TO NORMAL FUNCTION. SAFETY AND FUNCTIONAL TESTS WERE PERFORMED AND UNIT WAS RETURNED TO CUSTOMER.
UPDATED FIELDS: B4, G3, G6, H2, H11. CORRECTED FIELDS: E1 (EVENT SITE TELEPHONE), H6 (MEDICAL DEVICE ¿ PROBLEM CODE).
IT WAS REPORTED DURING ROUTINE CHECK THAT CS100 INTRA-AORTIC BALLOON PUMP (IABP) DISPLAY FLICKERING ISSUE. THERE WAS NO PATIENT INVOLVEMENT. NO ONE WAS HARMED ONSITE.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2587952 | CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0998-00-3013-55 | 10607567107295 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |