CARDIOSAVE HYBRID, TYPE B PLUG
Report
- Report Number
- 2249723-2023-01454
- Event Type
- Malfunction
- Date Received
- March 10, 2023
- Date of Event
- March 2, 2023
- Report Date
- July 22, 2024
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- 501
Narratives
UPDATED FIELDS: B4, G3, G6, H2, H10, H11. CORRECTED FIELDS: E1(SITE COUNTRY), H6(INVESTIGATION FINDINGS). A GETINGE FIELD SERVICE ENGINEER STATED THAT FAILURE OBSERVED DURING OPERATION ¿OVER TEMPERATURE ALARM¿. HE TESTED CARDIOSAVE AND COULD NOT DUPLICATE FAILURE. EXAMINED FAULT LOGS AND OBSERVED NO LOG DETECTED THAT POINTS TO COMPRESSOR FAILURE. REPLACED COMPRESSOR, FRONT END BOARD, TEMPERATURE SENSOR AND ALL FILTERS AS PRECAUTIONARY MEASURE TO ADDRESS OVER TEMPERATURE ALARM. UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS, RETURNED TO CUSTOMER AND CLEARED FOR CLINICAL USE. THE DEFECTIVE COMPONENTS WERE RECEIVED FOR FURTHER INVESTIGATION. THE FRONT-END BOARD PART NUMBER WAS OBSERVED PER THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION Q WITH NO VISUAL DAMAGE. THE FAILURE ANALYSIS AND TESTING DEPT. INSTALLED THE FRONT-END BOARD SERIAL NUMBER (B)(6) INTO THE CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE FRONT-END BOARD TO FACTORY SPECIFICATIONS PER PROCEDURE NUMBER 0002-07-D016 REVISION D AND THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION Q. NO PROBLEM WAS FOUND WITH THE FRONT-END BOARD (OVER TEMP FAILURE). TESTED OK. PASSED ALL TESTS AFTER OVER 5 HOURS OF CONTINUOUS RUN TIME. THE FRONT-END BOARD WILL BE HELD TO THE FAT DEPT. PER PROCEDURE NUMBER 0002-07-D008 REVISION AL. THE FAILURE ANALYSIS AND TESTING DEPT. INSTALLED THE MUFFLERS P/N0103-00-0449, 0103-00-0631 AND 0103-00-0709 INTO THE CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE MUFFLERS TO FACTORY SPECIFICATIONS PER PROCEDURE NUMBER 0002-07-D016 REVISION D AND THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION Q. NO PROBLEM WAS FOUND WITH THE MUFFLERS. TESTED OK. PASSED ALL TESTS AFTER OVER 5 HOURS OF CONTINUOUS RUN TIME. THE MUFFLERS WILL BE HELD TO THE FAT DEPT. PER PROCEDURE NUMBER 0002-07-D008 REVISION AL. THE FAILURE ANALYSIS AND TESTING DEPT. INSTALLED THE COMPRESSOR P/N 0119-00-0236 S/N (B)(6) INTO THE CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE COMPRESSOR TO FACTORY SPECIFICATIONS PER PROCEDURE NUMBER 0002-07-D016 REVISION D AND THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION Q. THE FAT DEPT. COULD NOT VERIFY THE FAILURE OF THE COMPRESSOR "OVER TEMP FAILURE". THE FAT DEPT. RAN THE SYSTEM FOR MULTIPLE HOURS (5HRS) TO SEE IF THE SYSTEM WOULD FAIL OVER TIME BUT NO FAILURE WAS OBSERVED. RETAINING THE COMPRESSOR IN THE FAT DEPT. PER PROCEDURE 0002-07-D008 REV AL. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0670-00-1164 PCB, FRONT END, ROHS SERIAL NUMBER (B)(6) FROM THE SUPPLIER. THE SUPPLIER REPLACED J2 AND THE BOX BUILD ASSEMBLY. THE BOARD PASSED TESTING. THE FAILURE ANALYSIS AND TESTING DEPT. INSTALLED PART NUMBER 0670-00-1164 PCB, FRONT END, ROHS SERIAL NUMBER (B)(6) INTO THE CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE BOARD TO FACTORY SPECIFICATIONS PER PROCEDURE NUMBER 0002-07-D016 REVISION E AND THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION R. THE BOARD PASSED TESTING. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE NOT CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED.
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
UPDATED FIELDS: B4, D9, E1(SITE COUNTRY), G3, G6, H2, H3, H4, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H10. ADDITIONAL INFORMATION: (B)(6). IT WAS REPORTED THAT WHILE USE ON A PATIENT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A OVER HEATING ISSUE. NO PATIENT HARM REPORTED. A GETINGE FIELD SERVICE ENGINEER STATED THAT FAILURE OBSERVED DURING OPERATION ¿OVER TEMPERATURE ALARM¿. HE TESTED CARDIOSAVE AND COULD NOT DUPLICATE FAILURE. EXAMINED FAULT LOGS AND OBSERVED NO LOG DETECTED THAT POINTS TO COMPRESSOR FAILURE. REPLACED COMPRESSOR, FRONT END BOARD TEMPERATURE SENSOR AND ALL FILTERS AS PRECAUTIONARY MEASURE TO ADDRESS OVER TEMPERATURE ALARM. UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS, RETURNED TO CUSTOMER AND CLEARED FOR CLINICAL USE.THE DEFECTIVE COMPONENTS WERE RECEIVED FOR FURTHER INVESTIGATION.THE FAT RECEIVED FRONT END BOARD, SCROLL COMPRESSOR AND MUFFLERS FOR EVALUATION. THE FAT DEPT. COULD NOT VERIFY THE FAILURE OF THE COMPRESSOR "OVER TEMP FAILURE" ,FRONT END BOARD (OVER TEMP FAILURE) ,MUFFLERS. THE FRONT END BOARD WILL BE HELD TO THE FAT DEPT. PER PROCEDURE NUMBER REVISION AL. THE MUFFLERS WILL BE HELD TO THE FAT DEPT. PER PROCEDURE NUMBER REVISION AL. RETAINING THE COMPRESSOR IN THE FAT DEPT. PER PROCEDURE REV AL.THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE NOT CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED.
N/A.
IT WAS REPORTED THAT DURING USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT OVERHEATING, WAS REMOVED FROM SERVICE AND REQUESTED A TECHNICIAN TO LOOK AT IT . THERE WAS NO PATIENT HARM REPORTED.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 448954 | CARDIOSAVE HYBRID, TYPE B PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. - MAHWAH | 0998-00-0800-53 | 10607567108391 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Prefer Not To Disclose | UNKNOWN. |