CARDIOSAVE HYBRID, TYPE B PLUG
Report
- Report Number
- 2249723-2024-02238
- Event Type
- Malfunction
- Date Received
- May 30, 2024
- Date of Event
- May 16, 2024
- Report Date
- October 3, 2024
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
A GETINGE FIELD SERVICE ENGINEER (FSE) CONFIRMED THE ISSUE AND CAUSED BY LEAKAGE FROM THE SOLENOID VALVE OF THE PNEUMATIC INTERFACE MODULE (PIM). REPLACED THE PIM ASSEMBLY (D997-00-1178). REGULAR CALIBRATION WAS PERFORMED. REPLACED THE BATTERY AND SCREW KIT FOR THE ALARM DAUGHTER BOARD. INSPECTION BASED ON THE INSPECTION RECORD SHEET SHOWED GOOD RESULTS. IT PASSED ALL FUNCTIONAL AND SAFETY TESTS BASED ON THE SERVICE MANUAL AND HAS BEEN RETURNED TO THE HOSPITAL. THERE WAS NO PATIENT INVOLVEMENT.
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
UPDATED FIELDS: B4, G3, G6, H2, H11. CORRECTED FIELDS: E1.
UPDATED FIELDS: B4, D9, E1(EVENT SITE POSTAL CODE - 8930022), G3, G6, H2, H3, H4, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS), H10. A GETINGE FIELD SERVICE ENGINEER SAYS MACHINE HAS NOT YET BEEN REPAIRED BECAUSE PARTS HAVE NOT YET ARRIVED. DESPITE GFES (GOOD FAITH EFFORTS), NO RESPONSE HAS BEEN RECEIVED REGARDING ANY REPAIR OR THE STATUS OF THE IABP. IF ANY PERTINENT INFORMATION IS RECEIVED IN THE FUTURE, THE COMPLAINT WILL BE REOPENED AND UPDATED ACCORDINGLY. H3 OTHER TEXT : NO REPAIR INFORMATION.
CORRECTED FIELDS: D4 (UDI#), E1 (EVENT SITE TELEPHONE) THE FOLLOWING INVESTIGATION WAS PERFORMED BY TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT). THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0997-00-1178 PNEUMATIC MODULE ASSY, SERIAL NUMBER (B)(6) WITH A REPORTED UNIT FAILURE OF AUTOMATIC FILLING ERROR OCCURRED. 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 0997-00-1178 PNEUMATIC MODULE ASSY, SERIAL NUMBER (B)(6). INTO THE CARDIOSAVE TEST FIXTURE AND TESTED THE PNEUMATIC MODULE TO FACTORY SPECIFICATIONS PER PROCEDURE AND THE CARDIOSAVE SERVICE MANUAL. THE FAT DEPT. PROCEEDED TO PERFORM THE ALL MANIFOLD TEST. WHEN IT WAS INDICATED TO PLUG THE DISK, THE FAT DEPT. PLUGGED THE DISK, HOWEVER THE DISPLAY READ PLEASE PLUG DISK. THE SYSTEM COULD NOT ACKNOWLEDGE THAT THE PNEUMATIC MODULE WAS PLUGGED. THIS IS AN INDICATION THAT THERE IS A LARGE LEAK WITHIN THE PNEUMATIC MODULE ASSEMBLY. THIS WAS THE PROBABLE CAUSE OF THE COMPLAINT OF AUTOMATIC FILLING ERROR. THE PNEUMATIC MODULE ASSEMBLY FAILED TESTING. RETAINING THE PNEUMATIC MODULE ASSEMBLY IN THE FAT DEPT. PER PROCEDURE.
IT WAS REPORTED THAT DURING ROUTINE INSPECTION BY HOSPITAL STAFF, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD AN AUTOMATIC FILLING ERROR. THERE WAS NO PATIENT INVOLVEMENT.
N/A.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1149507 | CARDIOSAVE HYBRID, TYPE B PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. - MAHWAH | 0998-00-0800-53 | 10607567108391 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |