CARDIOSAVE HYBRID, TYPE B PLUG
Report
- Report Number
- 2249723-2024-02926
- Event Type
- Malfunction
- Date Received
- July 22, 2024
- Date of Event
- July 1, 2024
- Report Date
- September 9, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AK, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID.
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
UPDATED FIELDS: B4, B5, B6, B7, D8, D9, D10, G1 (CONTACT PERSON MFG SITE), G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS), H11. H4 (MANUFACTURE DATE) SHOULD BE LEFT BLANK. KINDLY REVERT. DUE TO CHARACTER LIMIT IN BLOCK E1 INITIAL REPORTER: (B)(6). A (B)(4) FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND REPLACED THE DISPLAY MONITOR TO THE VIDEO GEN KIT (0040-00-0456). THE UNIT PASSED ALL FUNCTIONAL/SAFETY TESTING AND WAS RETURNED TO THE CUSTOMER FOR CLINICAL USE. THE FOLLOWING WAS PERFORMED BY THE SR SERVICE TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. WAYNE, NJ. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER: 0670-00-1183 C UPPER DISPLAY MONITOR BOARD, SERIAL NUMBER: (B)(6), PART NUMBER: 0670-00-1182 F VIDEO GENERATOR BOARD, SERIAL NUMBER: (B)(6) AND PART NUMBER: 0012-00-1558 CABLE, SERIAL NUMBER: (B)(6) AND PART NUMBER: 0012-00-1845 A, SERIAL NUMBER: (B)(6) WITH A REPORTED UNIT FAILURE OF STREAKS IN DISPLAY. THE FAT DEPT. PERFORMED A VISUAL INSPECTION OF ALL PARTS RECEIVED AND FOUND THAT ALL THE PARTS ARE IN GOOD CONDITION. THE FAT DEPT. INSTALLED PART NUMBER: 0670-00-1183 C, SERIAL NUMBER: (B)(6), PART NUMBER: 0670-00-1182 F, SERIAL NUMBER: (B)(6) AND PART NUMBER: 0012-00-1558, SERIAL NUMBER: (B)(6) AND PART NUMBER: 0012-00-1845 A, SERIAL NUMBER: (B)(6) IN THE CARDIOSAVE TEST FIXTURE, SERIAL NUMBER (B)(6) AND TESTED JOINTLY AND SEPARATELY IN ACCORDANCE WITH FACTORY SPECIFICATIONS PER PROCEDURE NUMBER 0002-07-D016 REVISION E AND THE CARDIOSAVE SERVICE MANUAL NUMBER 0070-00-0639 REV. R. THE FAILURE ANALYSIS AND TESTING DEPARTMENT FOUND THAT AFTER TURNING ON THE TEST FIXTURE THE DISPLAY STAYS BLACK. CAUSED BY P/N: 0670-00-1182 VIDEO GENERATOR BOARD. THE FAILURE ANALYSIS AND TESTING DEPARTMENT COULDN¿T REPLICATE THE FAILURE EXPERIENCED BY THE CUSTOMER. HOWEVER, THE FAT DEPT. WAS ABLE TO VERIFY THAT P/N: 0670-00-1182 VIDEO GENERATOR BOARD IS DEFECTIVE. SENDING THE BOARDS TO THE RESPECTIVE SUPPLIER FOR FURTHER FAILURE ANALYSIS AS PER PROCEDURE NUMBER 0002-07-D008 REV. AR. RETAINING THE CABLES IN THE FAT DEPT. PER PROCEDURE 0002-07-D008 REV. AR. THE FOLLOWING WAS SUBMITTED BY THE TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ. FAILURE ANALYSIS RECEIVED FROM THE SUPPLIER FOR THE PART 0670-00-1182. THEY STATED: FCT: TOUCHSCREEN FAIL TEST (U41), HTTP PCI BUS (U43), DSP PROGRAMMING FAILED SUSPECTED DEFECTIVE COMPONENT: U41, U43 (STREAKS IN DISPLAY) PROBABLE ROOT CAUSE FOR THIS PART IS IMPOSSIBLE TO DEFINE. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AS. THE FOLLOWING WAS SUBMITTED BY (B)(4), TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ. FAILURE ANALYSIS RECEIVED FROM THE SUPPLIER FOR THE PART 0670-00-1183. THEY STATED THE PART PASSED TESTING. ROOT CAUSE FOR THIS PART IS NOT CONFIRMED. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AS.
UPDATED FIELDS: B4, G3, G6, H2. H6 (INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11.
IT WAS REPORTED THAT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT' SCREEN HAS COLORED LINES. AFFECTING THE EKG AND OTHER VITALS. NO PATIENT INVOLVEMENT REPORTED.
IT WAS REPORTED THAT DURING USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) SCREEN HAD COLORED LINES WHICH AFFECTED THE ECG AND OTHER VITALS. THERE WAS A PATIENT INVOLVEMENT AND NO HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 737851 | 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 |