CARDIOSAVE HYBRID, TYPE B PLUG
Report
- Report Number
- 2249723-2025-0004318
- Event Type
- Malfunction
- Date Received
- October 15, 2025
- Date of Event
- September 24, 2025
- Report Date
- December 20, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
DUE TO CHARACTER LIMITATION IN E1 FOR EVENT SITE NAME, EVENT SITE NAME - (B)(6) MEDICAL CENTER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
UPDATED DATA: B4, G3, G6, H1, D9, H2, H11, H3, H6 (TYPE OF INVESTIGATION, MEDICAL DEVICE ¿ PROBLEM CODE INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), E1 (INITIAL REP NAME). CORRECTED FIELD: MANUFACTURE DATE: NOT AVAILABLE. FULL INITIAL REPORTER NAME: (B)(6). THERE WAS NO PATIENT INVOLVED. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND VERIFIED IN LOGS ERROR CODE RELATED TO POWER MANAGEMENT PCB. FSE REPLACED THE POWER MANAGEMENT BOARD (0670-00-1162) AS A PRECAUTION AND PERFORMED TEST. ALL FUNCTIONAL AND SAFETY CHECKS ARE MEET TO FACTORY SPECIFICATIONS PERFORMED AND PASSED.THE FOLLOWING INVESTIGATION WAS PERFORMED BY CARL FAMULARE, TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) (B)(6) (B)(6) 2025. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0670-00-1162 SERIAL NUMBER (B)(6) WITH A REPORTED UNIT FAILURE OF DEVICE FAILED TO BOOT UP, AND CODE 139. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE 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 CARDIOSAVE BOOTED UP WITH NO PROBLEM FOUND. AFTER A RUN-TIME OF 1.5 HOURS, THE FAT DID NOT OBSERVE ERROR CODE 139. THE FAT DEPT. COULD NOT REPLICATE THE UNIT NOT BOOTING UP AND COULD NOT REPLICATE ERROR CODE 139. THE BOARD PASSED TESTING. RETAINING THE BOARD IN THE FAT DEPT. PER PROCEDURE NUMBER 0002-07-D008 REV. AU. RC1 ¿ THERE IS NO SURGE PROTECTION IN THE INTERFACE BETWEEN THE CHARGING CIRCUITRY AND THE BATTERIES INSTALLED IN THE POWER SLOTS OF THE UNIT. RC2 ¿ 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. CAPA 566812 ROOT CAUSE #1: SERIAL DATA FROM THE POWER MANAGEMENT BOARD IS SENT WHILE THE EXECUTIVE BOARD IS STILL POWERING UP. MOST OF THE TIME THE EXECUTIVE BOARD CAN DEAL WITH THE EXCESS SERIAL DATA WITHOUT INCIDENT. HOWEVER, IN THE FAILURE CASE THE EXECUTIVE BOARD THROWS AN ERROR THAT IS NOT HANDLED CORRECTLY AND CAUSES THE UNIT TO GO INTO SYSTEM FAILURE. -CAPA 539589.
IT WAS REPORTED THAT PRIOR TO USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS ALARMING AND WILL NOT BOOT. THERE WAS NO PATIENT INVOLVEMENT.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2020472 | CARDIOSAVE HYBRID, TYPE B PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0998-00-0800-53 | 10607567108391 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |