CARDIOSAVE HYBRID, TYPE B PLUG
Report
- Report Number
- 2249723-2024-00214
- Event Type
- Malfunction
- Date Received
- January 17, 2024
- Date of Event
- January 9, 2024
- Report Date
- November 12, 2024
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE IABP UNIT AND UPON ARRIVAL DEVICE FOUND TO PRODUCE CONTINUOUS ALARM UNDER BOTH OF THE FOLLOWING CONDITIONS: WHEN TURNED ON, WHILE ON BATTERY POWER. IMMEDIATELY WHEN PLUGGED INTO AC POWER. LOGS FOUND INCLUDE 118 AND 139. UNDER GUIDANCE OF THE SERVICE MANUAL, SOLENOID CONTROL AND POWER MANAGEMENT BOARD WERE REPLACED TO RESOLVE ALL ISSUES. CALIBRATIONS, FUNCTIONAL TESTING, AND SAFETY TESTING ALL PASSED PER FACTORY SPECIFICATIONS. DEVICE RETURNED TO CUSTOMER.
THE FOLLOWING INVESTIGATION WAS PERFORMED BY TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT). THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PN 0670-00-1162 REV. G, SN (B)(6). PN 0670-00-1161 REV. B, SN (B)(6). PARTS WERE RECEIVED WITH A REPORTED FAILURE OF A CONTINUOUS ALARM WHILE IN BATTERY AND AC POWER. ALSO HAD ERROR CODES 118 AND 139. PERFORMED A VISUAL INSPECTION FOUND THE PARTS TO BE IN GOOD CONDITION. THE FAT INSTALLED PN 0670-00-1162 IN CARDIOSAVE TEST FIXTURE AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL. NO FAILURE WAS CONFIRMED. THE BOARD WAS WORKING PROPERLY. THE FAT INSTALLED PN 0670-00-1161 IN CARDIOSAVE TEST FIXTURE AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL. CONFIRMED THE REPORTED FAILURE BUT NO ROOT CAUSE DEFINED. SENT THE BOARDS TO THE SUPPLIER FOR FAILURE ANALYSIS PER PROCEDURE. THE FOLLOWING WAS SUBMITTED BY TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT). FAILURE ANALYSIS RECEIVED FROM THE SUPPLIER FOR THE PARTS LISTED ABOVE: THEY STATED FOR PN PN 0670-00-1162: BOARD WAS RE-TESTED AT FCT RESULT: FAILED STEP: 4.10.5.6.2 "CHANNEL ADC6 - VBULK_MON, CHECK VOLTAGE" 4.10.5.6.3 "CHANNEL ADC6 - VBULK_MON, VENIFY VOLTAGE" 3. PERFORM TROUBLESHOOTING ON THE BOARD. FOUND Q35 DEFECTIVE. FOR PN 0670-00-1161: BOARD WAS RE-TESTED AT FCT. RESULT: FAILED STEP $0227 4.3.6 ISOLATION VALVE. K4 (LED ON). 3. PERFORM TROUBLESHOOTING ON THE BOAR D. FOUND C38 DEFECTIVE. PROBABLE ROOT CAUSE FOR THESE PARTS IS A MANUFACTURING ASSEMBLY ISSUE. RETAINING THE PARTS IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE. PER CAPA # 566812. ROOT CAUSE 2 ¿ THE TANTALUM CAPACITORS USED ON THE FOLLOWING TWO (2) PCBAS ARE NOT WITHIN THE CAPACITOR MANUFACTURER¿S (VISHAY) DE-RATING GUIDELINES WHICH MAY RESULT IN CAPACITOR FAILURE CAUSING AN OVERCURRENT CONDITION ON THE VBULK POWER SUPPLY WHICH DAMAGES THE POWER MANAGEMENT BOARD. 0670-00-1161 PCBA, CARDIOSAVE ROHS SOLENOID CONTROL. 0670-00-1162 PCBA, CARDIOSAVE ROHS POWER MANAGEMENT.
IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) BATTERIES DIED IN TRANSPORT AND ARE ALARMING. THERE WAS NO KNOWN HARM.
N/A.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1773531 | 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 | Unknown | UNKNOWN. |