CARDIOSAVE HYBRID, TYPE B PLUG
Report
- Report Number
- 2249723-2025-0003745
- Event Type
- Malfunction
- Date Received
- September 8, 2025
- Date of Event
- August 15, 2025
- Report Date
- February 23, 2026
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
UPDATED DATA: B4, G3, G6, H1, H2, H11, H6 (INVESTIGATION FINDINGS) A GETINGE FIELD SERVICE ENGINEER (FSE) VERIFIED THE DAMAGED DISPLAY, REPLACED THE TOP DISPLAY LCD (0160-00-0127) AND LABELS (0334-00-1809 / 0334-00-1810-01). THE FSE WAS UNABLE TO CLOSE OUT SERVICE ORDER DUE TO THE BATTERIES BEING EXPIRED. THE FSE RECEIVED THE BATERRIES (B)(6) AND REPLACED IT. THE UNIT PASSED AND COMPLETED ALL FUNCTIONAL, SAFETY, CALIBRATION, AND PERFORMANCE CHECKS TO FACTORY SPECIFICATIONS. THE UNIT WAS RESTORED TO PROPER OPERATION.THE FOLLOWING WAS PERFORMED BY (B)(6), TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING (FAT) (B)(6).THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE FOLLOWING PART ASSOCIATED WITH THIS COMPLAINT: PN: 0160-00-0127 SN: (B)(6) DISPLAY TOP LCDTHIS PART WAS RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF ¿DEFECTIVE DISPLAY(DAMAGE)¿.THE FAILURE ANALYSIS AND TESTING DEPARTMENT PERFORMED A VISUAL INSPECTION, AND FOUND THE DISPLAY WAS DAMAGED. VISIBLE PHYSICAL DAMAGE WAS OBSERVED ON THE LCD SCREEN SURFACE. PLEASE REFER TO ATTACHED PICTURE FOR REFERENCE. NO FURTHER TESTING WAS PERFORMED DUE TO THE OBSERVED PHYSICAL DAMAGE CONDITION. THE FAT DEPT, VERIFIED THE FAILURE MESSAGE OF DEFECTIVE DISPLAY(DAMAGE)¿. RETAINING DISPLAY TOP LCD IN THE FAT DEPT. PER PROCEDURE 0002-07-D008 REV AU.
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
DUE TO CHARACTER LIMITATION: FULL INITIAL REPORTER NAME: (B)(6). UPDATED FIELDS: B4, D9, E1 (INITIAL REPORTER, EVENT SITE ADDRESS), G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS, COMPONENT CODES), H11. CORRECTED FIELDS: H6 (MEDICAL DEVICE ¿ PROBLEM CODE). IT WAS REPORTED BY THE BIOMED DEPARTMENT THAT THE CUSTOMER DAMAGED THE UPPER SCREEN PRIOR TO USE. THERE WAS NO INDICATION OF ACTUAL OR POTENTIAL HARM. A GETINGE TECHNICIAN VERIFIED THE DAMAGED DISPLAY, REPLACED THE LCD AND LABELS, AND COMPLETED ALL FUNCTIONAL, SAFETY, CALIBRATION, AND PERFORMANCE CHECKS TO FACTORY SPECIFICATIONS. THE UNIT WAS RESTORED TO PROPER OPERATION. THE PART WAS RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF ¿DEFECTIVE DISPLAY(DAMAGE)¿. THE FAILURE ANALYSIS AND TESTING DEPARTMENT PERFORMED A VISUAL INSPECTION, AND FOUND THE DISPLAY WAS DAMAGED. VISIBLE PHYSICAL DAMAGE WAS OBSERVED ON THE LCD SCREEN SURFACE. NO FURTHER TESTING WAS PERFORMED DUE TO THE OBSERVED PHYSICAL DAMAGE CONDITION. THE FAT DEPT, VERIFIED THE FAILURE MESSAGE OF DEFECTIVE DISPLAY (DAMAGE)¿. RETAINING DISPLAY TOP LCD IN THE FAT DEPT.
N/A
IT WAS REPORTED THAT PRIOR TO USE, CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD THE UPPER SCREEN DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 498175 | 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 |