CARDIOSAVE HYBRID TYPE D PLUG
Report
- Report Number
- 2249723-2025-0003213
- Event Type
- Malfunction
- Date Received
- July 28, 2025
- Date of Event
- July 14, 2025
- Report Date
- April 2, 2026
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567109008
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
UPDATED FIELDS: B4, D9, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11. THE FSE CHECKED THE DEVICE AND CONFIRMED THE ABOVE ISSUE. VERIFIED MAINS SUPPLY AND BATTERIES ARE OK. CHECKED THE SERVICE DIAGNOSTICS AND FOUND ERROR OF PMB BOARD. RESET THE CONNECTIONS BETWEEN POWER MANAGEMENT BOARD & EXECUTIVE PROCESSOR BOARD AND THEIR MOUNTING CONNECTORS BUT STILL PROBLEM PERSIST. REQUIRED PMB BOARD FOR FURTHER TESTING. REQUIRED SPARE: POWER MANAGEMENT BOARD. THE FINAL REPAIR IS NOT CONDUCTED YET.
UPDATED FIELD ; B4 , G3 , G6 , H2 , H11 , D9 , H6 ( TYPE OF INVESTIGATION ). A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE FSE CHECKED THE DEVICE AND CONFIRMED THE ABOVE ISSUE. VERIFIED MAIN SUPPLY AND BATTERIES ARE OK. CHECKED THE SERVICE DIAGNOSTICS AND FOUND ERROR OF PMB BOARD. RESET THE CONNECTIONS BETWEEN POWER MANAGEMENT BOARD & EXECUTIVE PROCESSOR BOARD AND THEIR MOUNTING CONNECTORS BUT STILL PROBLEM PERSIST. A RETURN VISIT FOUND BURN TRACES ON THE SOLENOID CONTROL BOARD. BOTH THE POWER MANAGEMENT BOARD (0670-00-1162) AND THE SOLENOID CONTROL BOARD (0670-00-1161) WERE REPLACED. THE UNIT BOOTED UP SUCCESSFULLY AND REQUIRE BATTERY MAINTENANCE TEST, THE TEST PASSED AS WELL. DEVICE PASSED THE PERFORMANCE AND SAFETY CHECKS ACCORDING TO FACTORY SPECIFICATIONS. THE FAILURE ANALYSIS AND TESTING DEPT RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT. PART NUMBER 0670 00 1161 PCB SOLENOID CONTROL SERIAL NUMBER (B)(6). PART NUMBER 0670 00 1162 PCB POWER MANAGEMENT ROHS SERIAL NUMBER (B)(6). THESE PARTS WERE RECEIVED WITH A REPORTED UNIT FAILURE OF NOT BOOTING UP. THE FAILURE ANALYSIS AND TESTING DEPT PERFORMED A VISUAL INSPECTION AND FOUND PART NUMBER 0670 00 1162 PCB POWER MANAGEMENT ROHS SERIAL NUMBER (B)(6) TO BE IN GOOD CONDITION. PART NUMBER 0670 00 1161 PCB SOLENOID CONTROL SERIAL NUMBER (B)(6) HAS A SHORTED COMPONENT C12. PLEASE SEE ATTACHMENT. DUE TO THE SHORTED COMPONENT, THE FAT DEPT CANNOT INVESTIGATE THIS BOARD ANY FURTHER. PART NUMBER 0670 00 1162 PCB POWER MANAGEMENT ROHS SERIAL NUMBER (B)(6) WAS FOUND IN GOOD CONDITION. THE FAILURE ANALYSIS AND TESTING DEPT INSTALLED PART NUMBER 0670 00 1162 PCB POWER MANAGEMENT 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 F AND THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070 00 0639 REVISION R. THE FAT DEPT WAS ABLE TO REPLICATE THE COMPLAINT OF THE UNIT NOT BOOTING UP. THE BOARD FAILED TESTING. SENDING PART NUMBER 0670 00 1162 PCB POWER MANAGEMENT ROHS SERIAL NUMBER (B)(6) TO THE SUPPLIER PER PROCEDURE NUMBER 0002 07 D008 REV AU. RETAINING PART NUMBER 0670 00 1161 PCB SOLENOID CONTROL SERIAL NUMBER (B)(6) IN THE FAT DEPT PER PROCEDURE NUMBER 0002 07 D008 REV AU. THE FOLLOWING WAS SUBMITTED BY (B)(4) TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT, FAT, WAYNE NJ, AR, 31 MARCH 2026. FAILURE ANALYSIS RECEIVED FROM THE SUPPLIER FOR PART NUMBER 0670 00 1162. PLEASE SEE ATTACHMENT. THEY STATED: 1 PERFORM VISUAL CHECK RESULT NO ABNORMALITY FOUND 2 BOARD WAS RE TESTED AT FCT RESULT FAILED STEP 8 9 13 3 BCP SLOT 2 DCIN BAT BATDIS AT TP67 3 PERFORM TROUBLESHOOTING ON THE BOARD FOUND Q31 Q33 Q35 DEFECTIVE ROOT CAUSE FOR THIS PART IS DUE TO DEFECTIVE COMPONENTS. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002 07 D008 REV.
DUE TO CHARACTER RESTRICTIONS IN BLOCK E1 EVENT SITE NAME: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
UPDATED DATA: B4, G3, G6, H1, H2, H11 CORRECTED DATA: H6 (INVESTIGATION CONCLUSIONS ).
N/A.
IT WAS REPORTED THAT DURING ROUTINE CHECK BY END USER, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) MACHINE IS NOT BOOTING UP. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1622652 | CARDIOSAVE HYBRID TYPE D PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0998-00-0800-33 | 10607567109008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |