CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
Report
- Report Number
- 2249723-2025-0004834
- Event Type
- Malfunction
- Date Received
- November 25, 2025
- Date of Event
- November 3, 2025
- Report Date
- April 16, 2026
- 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
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
UPDATED FIELDS: B4, G3, G6, H2. ADDITIONA INITIAL REP NAME: A/P (DETRA'S BACKUP) (B)(6)CORRECTED FIELD: H11, H6 (COMPONENT CODES). IT WAS REPORTED THAT DURING ROUTINE CHECK THE CS300 INTRA AORTIC BALLOON PUMP (IABP) BATTERY IS NOT CHARGING. THERE WAS NO PATIENT INVOLVED. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND OBSERVED NO AC OPERATION AND UNIT NOT CHARGING BATTERIES. THE FSE ISOLATED THE FAILURE TO A WORN AC POWER CORD AND REPLACED AC LINE CABLE (0012-00-0886-01). ALL FUNCTIONAL AND SAFETY TEST WERE PERFORMED AND PASSED.THE FOLLOWING INVESTIGATION WAS PERFORMED BY (B)(4), TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ: AR 6 FEB 2026. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0012-00-0886-01 WITH A REPORTED UNIT FAILURE OF NO AC POWER TO THE PUMP. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN A WORN-DOWN CONDITION. TESTED THE CONTINUITY OF THE CABLE WITH A MULTIMETER AND FOUND ONE OF THE WIRES WAS FAULTY. THIS WOULD CAUSE THE PART TO FAIL TO PROVIDE POWER. POSSIBLE CAUSE IS THE WEAR AND TEAR. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER (B)(6). THE MOST PROBABLE ROOT CAUSE PER DFMEA IS EXCESSIVE STRESS OR FATIGUE.
UPDATED FIELD : B4 , G3 , G6 , H2 , H11 , H6 ( TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS). CORRECTED FIELD : B5 , D10 , E1 (INITIAL REPORTER), E3, H6 (MEDICAL DEVICE ¿ PROBLEM CODE).
UPDATED FIELDS: B4, B5, B6, B8, D9, E3, G3, G6, H2, H6(INVESTIGATION TYPE, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION, COMPONENT CODE), H11. IT WAS REPORTED THAT DURING ROUTINE CHECK THE CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP) BATTERY IS NOT CHARGING. THERE WAS NO PATIENT INVOLVED. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND OBSERVED NO AC OPERATION AND UNIT NOT CHARGING BATTERIES. THE FSE ISOLATED THE FAILURE TO A WORN AC POWER CORD AND REPLACED AC LINE CABLE. ALL FUNCTIONAL AND SAFETY TEST WERE PERFORMED AND PASSED. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER WITH A REPORTED UNIT FAILURE OF NO AC POWER TO THE PUMP. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN A WORN DOWN CONDITION. TESTED THE CONTINUITY OF THE CABLE WITH A MULTIMETER AND FOUND ONE OF THE WIRES WAS FAULTY. THIS WOULD CAUSE THE PART TO FAIL TO PROVIDE POWER. POSSIBLE CAUSE IS THE WEAR AND TEAR. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE. THE MOST PROBABLE ROOT CAUSE PER DFMEA IS EXCESSIVE STRESS OR FATIGUE.
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
IT WAS REPORTED THAT DURING ROUTINE CHECK THE CS300 INTRA AORTIC BALLOON PUMP (IABP) BATTERY IS NOT CHARGING. THERE WAS NO PATIENT INVOLVED.
IT WAS REPORTED THAT DURING ROUTINE CHECK THE CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP) BATTERY IS NOT CHARGING. THERE WAS NO PATIENT INVOLVED.
IT WAS REPORTED THAT THE BATTERY OF CS300 INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT CHARGING. PATIENT WAS INVOLVED, IT STOPPED WORKING WHILE ON THE PATIENT. NO HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2812599 | 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 |