CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
Report
- Report Number
- 2249723-2025-0003126
- Event Type
- Malfunction
- Date Received
- July 23, 2025
- Date of Event
- July 9, 2025
- Report Date
- September 12, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567107882
- PMA / PMN Number
- K063525
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
CORRECTED FIELD : G7 ,H6 ( MEDICAL DEVICE ¿ PROBLEM CODE ) UPDATED FIELD : B4, G3 , G6 , H2 , H11.
UPDATED FIELDS: B4, G1, G3, G6, H2, H3, H6 (INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION, TYPE OF INVESTIGATION), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. FSE STATES, END USER OBSERVED FIBER OPTIC SENSOR FAILURE. TESTED CS300 AND EXAMINED FAULT LOGS AND OBSERVED NO FIBER OPTIC FAILURES LOGGED. PERFORMED FIBER OPTIC TEST AND PASSED TO SPECIFICATIONS. COULD NOT DUPLICATE FAILURE. UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS, RETURNED TO CUSTOMER. COMPLETED REPAIR SUCCESSFULLY. COMPLETED PRODUCT INSPECTION PER CUSTOMER/MANUFACTURER REQUIREMENTS.
DUE TO CHARACTER LIMITATION, EVENT SITE FULL NAME (E1):(B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
NA.
IT WAS REPORTED THAT CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD THE FIBER OPTIC FAILED. THERE WAS NO HARM OR INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1737887 | CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0998-00-3023-53 | 10607567107882 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | UNKNOWN. |