CARDIOSAVE HYBRID, TYPE B PLUG
Report
- Report Number
- 2249723-2024-02759
- Event Type
- Malfunction
- Date Received
- July 8, 2024
- Report Date
- May 12, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
**UDI RELATED DATA QUALITY UPDATES ONLY** PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID.
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
UPDATED FIELDS: B4,G3, G6,H2, H11 CORRECTED FIELDS: D8, D9, H3, H6 ( TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSION) IT WAS IDENTIFIED THAT THE DATE RECEIVED BY MFG MENTIONED IN THE PREVIOUS MDR 2249723-2024-02759 WAS INCORRECT HOWEVER THE CORRECT DATE RECEIVED BY MFG IS 10-FEB-2025. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS BEING DISPATCHED IN ORDER TO EVALUATE THE UNIT AND DURING THE PERIOD OF AN EVALUATION FSE WAS NOT ABLE TO DUPLICATE ANY FAILURE WITH THE IABP OR THE ECG TRUNK CABLE AND LEADWIRES FOR THE REPORTED ISSUE. ALL THE ECG GAIN CHECKS HAVE BEEN PASSED WITH A PATIENT SIMULATOR AND ALL THE SYSTEM TRAINER WAVEFORM VERIFICATION CHECKS HAD ALSO BEEN PASSED. FSE FOUND OUT THAT UNIT WAS NOT PRODUCING THE WAVEFORMS AND THERE WAS FIBER OPTIC TEST FAILURE. FSE HAD REPLACED THE ASSY, FIBER OPTIC ROHS TO RESOLVE THE IDENTIFIED ISSUE. THE FSE HAD ALSO FURTHER NOTICED THAT THERE IS HORIZONTAL LINE WHICH WAS PRESENT ON THE TOP LCD AS THE LCD WAS DEFECTIVE THEREFORE THE FSE HAD REPLACED THE ASSY, DISPLAY TOP LCD ROHS. FSE PERFORMED COMPLETE PM WITH FULL CALIBRATION, FUNCTIONAL TESTING AND ELECTRICAL SAFETY CHECKS ACCORDING TO THE FACTORY SPECIFICATIONS. THE UNIT WAS RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL USE. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED FIBER OPTIC MODULE WITH A REPORTED FAILURE OF EKG NOT WORKING. THE FIBER OPTIC MODULE ASSEMBLY IS MADE OF 17 CS30164_FISO AND 16 02504 48 SWEMCO. THE FAILURE ANALYSIS AND TESTING DEPARTMENT PERFORMED A VISUAL INSPECTION OF THE PARTS RECEIVED AND FOUND THAT ALL THE PARTS ARE IN GOOD CONDITION. THE FAILURE ANALYSIS AND TESTING DEPARTMENT INSTALLED FIBER OPTIC MODULE IN THE CARDIOSAVE TEST FIXTURE AND TESTED TO FACTORY SPECIFICATIONS IN ACCORDANCE WITH CARDIOSAVE SERVICE MANUAL AND IT PASSED ALL TESTS. THE FAILURE ANALYSIS AND TESTING DEPARTMENT COULD NOT VERIFY THE FIBER OPTIC FAILURE EXPERIENCED BY THE CUSTOMER. THE SUBPARTS OF THE ASSEMBLY WAS SENT TO THE RESPECTIVE SUPPLIER FOR MORE ANALYSIS PER PROCEDURE. FAILURE ANALYSIS RECEIVED FROM THE SUPPLIER FOR SUBPART 16 02504 48 SWEMCO. IT STATED THAT NO ABNORMALITIES FOUND UPON PERFORMING VISUAL CHECK. FURTHER BOARD WAS RE-TESTED AT FCT AND IT PASSED THE TEST RESULTS AT INSPECTION AND TEST IS GOOD AND NO ABNORMALITIES WAS DETECTED. BOARD WAS NDF. NO FAILURE CONFIRMED ON THIS PART. RETAINED THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE. FAILURE ANALYSIS RECEIVED FROM THE SUPPLIER FOR THE SUBPART 17 CS30164 FISO AND IT WAS REPORTED THAT THE PART FAILED AND THE OPTICAL BLOC NEEDED TO BE CHANGED. ROOT CAUSE FOR THIS PART IS IMPOSSIBLE TO DEFINE. RETAINED THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE.
UPDATED DATA: B4, G3, G6, H1, H2,H11, D9.
N/A
IT WAS REPORTED THAT DURING USE THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT ECG NOT REGISTERING AND NOT SHOWING ON DISPLAY. THERE WAS NO PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 903727 | CARDIOSAVE HYBRID, TYPE B PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0998-00-0800-53 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |