CARDIOSAVE HYBRID, 3.1 EDITION
Report
- Report Number
- 2249723-2023-04849
- Event Type
- Malfunction
- Date Received
- November 14, 2023
- Date of Event
- November 6, 2023
- Report Date
- July 18, 2025
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
UPDATED DATA: B4,G3,G6,H2,H10,H11.
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
A GETINGE FIELD SERVICE ENGINEER EVALUATED SCREEN DISPLAY FAILURE OCCURRED. THE FSE REPLACED THE EXECUTIVE PROCESSOR BOARD (0670-00-0770) AND VIDEO GENERATOR BOARD (0040-00-0456). THE INSPECTION RESULTS BASED ON THE INSPECTION RECORD SHEET WERE GOOD. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PN 0040-00-0456(KIT) PN 0670-00-1182 REV. F, SN (B)(6). PN 0670-00-1183 REV. C, SN (B)(6). PN 0012-00-1845 REV. A, SN (B)(6). PN 0670-00-0770 REV. S, SN (B)(6). PARTS WERE RECEIVED WITH A REPORTED FAILURE OF AN LCD DISPLAY FAILURE. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAT INSTALLED PN 0670-00-1182 IN CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6). AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION R. CONFIRMED THE FAILURE ON THIS PART WHEN THE DISPLAY FAILED TO SHOW THE IMAGE PROPERLY. THE FAT INSTALLED PN 0670-00-1183 IN CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION R. NO FAILURE CONFIRMED. THE FAT INSTALLED PN 0012-00-1845 IN CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6. AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION R. NO FAILURE CONFIRMED. THE FAT INSTALLED PN 0670-00-0770 IN CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION R. NO FAILURE CONFIRMED. RETAINING PN 0012-00-1845 IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AQ. SENDING THE REST OF THE BOARDS TO THE SUPPLIER FOR FAILURE ANALYSIS PER PROCEDURE NUMBER 0002-07-D008 REV. AQ. THE FAT DEPT. RECEIVED PART NUMBER 0670-00-1183 REV C, DISPLAY MONITOR BOARD SERIAL NUMBER (B)(6) FROM THE SUPPLIER. SUPPLIER INVESTIGATION: PERFORMED VISUAL CHECK AND NO ABNORMALITY FOUND. BOARD WAS RE-TESTED AT FCT AND PASSED. RESULT AT INSPECTION AND TEST IS GOOD AND NO ABNORMALITIES WAS DETECTED. BOARD WAS NDF. RETAINING THIS BOARD IN THE FAT DEPT. PER PROCEDURE 0002-07-D008 REV AR. THE FOLLOWING WAS SUBMITTED BY (B)(4), TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ: AR 14 OCT 2024. FAILURE ANALYSIS RECEIVED FROM THE SUPPLIER FOR PN 0670-00-0770. PLEASE SEE ATTACHMENT. THEY STATED THAT THE ICT TEST FAILED AND CR5 COMPONENT IS FAULTY. PROBABLE ROOT CAUSE IS DESIGN- DQ ISSUE. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AR. THE FOLLOWING WAS SUBMITTED BY (B)(4), TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ: AR 14 OCT 2024. FAILURE ANALYSIS RECEIVED FROM THE SUPPLIER FOR PN 0670-00-1182. THEY STATED THAT THE FCT TEST FAILED. U41 COMPONENT IS FAULTY. PROBABLE ROOT CAUSE IS A DESIGN ISSUE. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AR. INVESTIGATION IS COMPLETE.
UPDATED FIELDS: B4, D9 (RETURN TO MANUFACTURE DATE), G1 (CONTACT PERSON ¿ MFG SITE), G3, G6, H2, H11. CORRECTED FIELDS: H6 (COMPONENT CODES). IT WAS REPORTED THAT DURING USE THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A SCREEN DISPLAY FAILURE. THERE WAS NO HARM TO PATIENT. A GETINGE FIELD SERVICE ENGINEER EVALUATED THE UNIT AND NO ALARM WAS SOUNDING. THE FSE STATES DISPLAY MALFUNCTION DID OCCUR SO THE EXECUTIVE PROCESSOR BOARD AND VIDEO GENERATOR BOARD WAS REPLACED. THE INSPECTION RESULTS BASED ON THE INSPECTION RECORD SHEET WERE GOOD. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE PARTS ASSOCIATED WITH THIS COMPLAINT. PARTS WERE RECEIVED WITH A REPORTED FAILURE OF AN LCD DISPLAY FAILURE. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAT INSTALLED IN CARDIOSAVE TEST FIXTURE AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE MANUAL. CONFIRMED THE FAILURE ON THIS PART WHEN THE DISPLAY FAILED TO SHOW THE IMAGE PROPERLY. THE FAT INSTALLED IN CARDIOSAVE TEST FIXTURE AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE MANUAL. NO FAILURE CONFIRMED. THE FAT INSTALLED IN CARDIOSAVE TEST FIXTURE AND TESTED THE PART TO FACTORY SPECIFICATIONS PER MANUAL. NO FAILURE CONFIRMED. THE FAT INSTALLED IN CARDIOSAVE TEST FIXTURE AND TESTED THE PART TO FACTORY SPECIFICATIONS PER MANUAL. NO FAILURE CONFIRMED. RETAINING IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE. SENDING THE REST OF THE BOARDS TO THE SUPPLIER FOR FAILURE ANALYSIS PER COMPANY PROCEDURE. THE FAT DEPT. RECEIVED DISPLAY MONITOR FROM THE SUPPLIER. SUPPLIER INVESTIGATION: PERFORMED VISUAL CHECK AND NO ABNORMALITY FOUND. BOARD WAS RE-TESTED AT FCT AND PASSED. RESULT AT INSPECTION AND TEST IS GOOD AND NO ABNORMALITIES WAS DETECTED. BOARD WAS NDF. RETAINING THIS BOARD IN THE FAT DEPT. PER COMPANY PROCEDURE. FAILURE ANALYSIS RECEIVED FROM THE SUPPLIER. THEY STATED THAT THE ICT TEST FAILED AND CR5 COMPONENT IS FAULTY. PROBABLE ROOT CAUSE IS DESIGN- DQ ISSUE. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER COMPANY PROCEDURE. FAILURE ANALYSIS RECEIVED FROM THE SUPPLIER. THEY STATED THAT THE FCT TEST FAILED. U41 COMPONENT IS FAULTY. PROBABLE ROOT CAUSE IS A DESIGN ISSUE. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER COMPANY PROCEDURE. INVESTIGATION IS COMPLETE. THE MOST PROBABLE ROOT CAUSE FOR THE REPORTED FAILURE IS PCB RELIABILITY.
N/A.
IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT'S LCD SCREEN DISPLAY FAILURE. THERE WERE NO HEALTH RISKS TO PATIENTS.
N/A.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2203423 | CARDIOSAVE HYBRID, 3.1 EDITION | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. - MAHWAH | 0998-00-0800-65 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | UNKNOWN. |