CS300 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V
Report
- Report Number
- 2249723-2021-02337
- Event Type
- Malfunction
- Date Received
- October 13, 2021
- Date of Event
- September 20, 2021
- Report Date
- April 18, 2024
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567108322
- PMA / PMN Number
- K063525
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
TESTING OF ACTUAL DEVICE(10/3223): A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THIS UNIT. DURING INSPECTION THE REPORTED ISSUE WAS REPLICATED APPROXIAMETLY THREE TIMES WHEN THE UNIT WAS TURNED ON. HOWEVER, LATER ON THE ISSUE WOULD NOT REPLICATE WHEN RUNNING TEST USING A TEST BALLOON. THE REPAIR STARTED ON 22SEP2021 AND IS STILL ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION.
INSPECTION OF PCB,FRONT END MODULE, PCB,IABP MAIN BOARD, AND CABLE,FRONT END TO MAIN W/SYNC WAS COMPLETED PER PROCEDURE AT GETINGE'S NATIONAL REPAIR CENTER(NRC) WITH NO VISUAL DAMAGE OBSERVED. THE NRC PROCEEDED TO TEST EACH PART INDIVIDUALLY IN THE CS300 TEST FIXTURE TO FACTORY SPECIFICATIONS PER THE CS300 SERVICE MANUAL. THE PCB,FRONT END MODULE WAS TESTED AND THE NRC COULD NOT VERIFY THE FAILURE OF ERROR CODE 119. THE NRC THEN TESTED THE PCB,IABP MAIN BOARD BY ITSELF AND COULD NOT VERIFY THE FAILURE OF ERROR CODE 119. THE BOARD PASSED TESTING. THE CABLE,FRONT END TO MAIN W/SYNC WAS THEN INSTALLED INTO THE CS300 TEST FIXTURE. THE NRC COULD NOT VERIFY THE FAILURE OF CODE 119. THE CABLE PASSED TESTING. THE NRC THEN PROCEEDED TO INSTALL ALL THREE OF THE ABOVE PARTS INTO THE CS300 TEST FIXTURE, TO TEST THE PARTS TOGETHER. AFTER EXTENSIVE TESTING AND RUN TIME OF THE CARDIOSAVE TEST FIXTURE FOR 4 HOURS, THE NRC COULD NOT VERIFY THE FAILURE OF ERROR CODE 119. THE TWO BOARDS PASSED TESTING ,ALONG WITH THE CABLE ASSEMBLY. THE NRC WILL SEND THE BOARDS TO THEIR RESPECTIVE SUPPLIERS PER PROCEDURE. THE CABLE ASSEMBLY WILL BE RETAINED IN THE NRC PER PROCEDURE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS PROVIDED.
TESTING OF ACTUAL DEVICE(10/3223): THE GETINGE FIELD SERVICE ENGINEER (FSE) REPLACED THE FRONT END MODULE BOARD, MAIN BOARD, AND FRONT END TO MAIN CABLE. IT IS EXPECTED THAT THE SUSPECTED FAULTY REPLACED PARTS WILL BE RETURNED TO GETINGE'S NATIONAL REPAIR CENTER FOR FAILURE ANALYSIS; A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF FAILURE ANALYSIS.
ADDITIONAL INFORMATION: E1(POSTAL CODE: (B)(6) A GETINGE FIELD SERVICE ENGINEER EVALUATED THE UNIT AND RESOLVED THE ISSUE BY REPLACING PCB,FRONT END MODULE , 0670-00-0688, PCB,IABP MAIN BOARD, 0670-00-0788, CABLE,FRONT END TO MAIN W/SYNC, 0012-00-1537. FSE STATES THAT THE UNIT WAS CLEARED FOR CLINICAL USE AND RETURNED TO CUSTOMER ON 8 DECEMBER 2021. AFTER RETURNING TO THE FACILITY, THIS IABP UNIT IS CONFIRMED TO HAVE BEEN WORKING NORMALLY AT ROUTINE PREVENTIVE MAINTENANCE WITH NO ISSUES. THE DEFECTIVE COMPONENTS WERE RECEIVED FOR FURTHER INVESTIGATION. INSPECTION OF THE FOLLOWING PARTS WAS COMPLETED PER PROCEDURE NUMBER 0002-07-D014 REVISION G AND TO THE IPC-A-610 STANDARD REVISION H WITH NO VISUAL DAMAGE OBSERVED: PCB,FRONT END MODULE PART NUMBER 0670-00-0688 SERIAL NUMBER (B)(6) MAIN BOARD PART NUMBER 0670-00-0788 SERIAL NUMBER (B)(6) CABLE,FRONT END TO MAIN W/SYNC PART NUMBER 0012-00-1537 WAS VISUALLY INSPECTED PER THE CS300 SERVICE MANUAL PART NUMBER 0070-00-0689 REVISION V, WITH NO VISUAL DAMAGE OBSERVED. THE NATIONAL REPAIR CENTER PROCEEDED TO TEST EACH PART INDIVIDUALLY IN THE CS300 TEST FIXTURE SERIAL NUMBER (B)(6) TO FACTORY SPECIFICATIONS PER THE CS300 SERVICE MANUAL PART NUMBER 0070-00-0689 REVISION V. THE PCB,FRONT END MODULE PART NUMBER 0670-00-0688 SERIAL NUMBER (B)(6) . THE NRC COULD NOT VERIFY THE FAILURE OF ERROR CODE 119. THE NRC THEN TESTED THE PCB,IABP MAIN BOARD PART NUMBER 0670-00-0788 SERIAL NUMBER (B)(6) BY ITSELF. THE NRC COULD NOT VERIFY THE FAILURE OF ERROR CODE 119. THE BOARD PASSED TESTING. THE CABLE,FRONT END TO MAIN W/SYNC SERIAL NUMBER NA WAS THEN INSTALLED INTO THE CS300 TEST FIXTURE. THE NRC COULD NOT VERIFY THE FAILURE OF CODE 119.THE CABLE PASSED TESTING. THE NRC THEN PROCEEDED TO INSTALL ALL THREE OF THE ABOVE PARTS INTO THE CS300 TEST FIXTURE, TO TEST THE PARTS TOGETHER. AFTER EXTENSIVE TESTING AND RUN TIME OF THE CARDIOSAVE TEST FIXTURE FOR 4 HOURS, THE NRC COULD NOT VERIFY THE FAILURE OF ERROR CODE 119. THE TWO BOARDS PASSED TESTING ,ALONG WITH THE CABLE ASSEMBLY. RETAINING THE CABLE ASSEMBLY IN THE NRC PER PROCEDURE. SENDING THE BOARDS TO THEIR RESPECTIVE SUPPLIERS PER PROCEDURE NUMBER. THE FOLLOWING PARTS ARE NO LONGER GOING BACK TO SUPPLIER FOR FURTHER INVESTIGATION. PCB,FRONT END MODULE . THE FINAL INVESTIGATION COMPLETED BY FAT DEPT. RETAINING BOTH BOARDS IN THE FAT DEPT, AS PER PROCEDURE. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE NOT IDENTIFIED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED.
N/A.
N/A.
IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) DISPLAYED FAULT #119. CUSTOMER ATTEMPTED TO REBOOT THIS UNIT 5-6 TIMES, HOWEVER THE ISSUE WAS UNABLE TO BE RESOLVED SO CUSTOMER REMOVED IAB CATHETER AND THERAPY ENDED. THE PATIENT HEMODYNAMICS WAS REPORTED TO HAVE BEEN STABLE. THERE WAS NO HARM OR INJURY TO THE PATIENT AND NO ADVERSE EVENT WAS REPORTED.
N/A.
TYPE OF INVESTIGATION NOT YET DETERMINED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN OUR INVESTIGATION IS COMPLETED. NOT RETURNED TO MANUFACTURER.
IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) DISPLAYED FAULT #119. CUSTOMER POWERED UNIT ON/OFF SEVERAL TIMES WITH NO IMPROVEMENT. CUSTOMER REMOVED IABP. THERE WAS NO HARM OR INJURY TO THE PATIENT AND NO ADVERSE EVENT WAS REPORTED
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1523778 | CS300 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. - MAHWAH | 0998-00-3023-65 | N/A | 10607567108322 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Male | TRANS-RAY PLUS IAB CATHETER.| UNKNOWN. |