CARDIOSAVE HYBRID, TYPE B PLUG
Report
- Report Number
- 2249723-2023-04689
- Event Type
- Malfunction
- Date Received
- November 2, 2023
- Date of Event
- October 23, 2023
- Report Date
- September 5, 2024
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- 501
Narratives
UPDATED FIELD: B4, D9, G3, G6, H2, H3, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS),H10 CORRECTED FIELD: D4. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED TO EVALUATE THE IABP UNIT BECAUSE THE CUSTOMER'S BIOMED STATED THAT THE PUMP DID NOT REQUIRE ANY REPAIRS. AFTER THE BATTERIES WERE CHARGED FOR 24 HRS, BOTH BATTERIES WERE TESTED AT 120 BPM AND LASTED OVER 60 MINUTES BEFORE ALARMING. SINCE NO ISSUES WERE FOUND THE IABP WAS PUT BACK INTO SERVICE. AFTER TESTING THE BATTERIES THE PUMP WAS RAN THROUGH ALL MANUFACTURER RECOMMENDATION TESTS AND PROCEDURES. ALSO RUNNING ON SIMULATOR AFTERWARDS. ATTEMPTS WERE MADE TO OBTAIN THE CORRECT SERIAL# FOR THE IABP BECAUSE THE SERIAL# (B)(6) THAT WAS PROVIDED WAS FOUND NOT TO BE A VALID SERIAL NUMBER, BUT THE CUSTOMER HAS MOVED PUMPS AROUND AND THE FSE COULD NOT VERIFY THE CORRECT SERIAL#. H3 OTHER TEXT : DEVICE NOT AVAILABLE FOR EVALUATION.
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
UPDATED DATA: B4, D4 (SERIAL#), G3, G6, H2, H10.
**UDI RELATED DATA QUALITY UPDATES ONLY** PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID.
N/A.
IT WAS REPORTED THAT THE BATTERIES ON THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) ONLY LASTED 10 MINUTES DURING A TRANSPORT. THE CCP CALLED TO GET HELP WITH THE PUMP . IT WAS ADVISED THAT GE PROVIDES ALL PM AND REPAIR SERVICES FOR THE PUMPS AND THAT GETINGE DOES NOT PM OR REPAIR THE UNITS AT HER HOSPITAL. THE CCP STATED SHE WOULD FOLLOWING UP WITH HER GE BIOMED TEAM. SHE WAS PROVIDED WITH THE CARDIOSAVE BATTERY OPERATION QUICK REFERENCE GUIDE AND CARDIOSAVE TRANSPORT QRG FOR RESOURCES. THERE WAS NO PATIENT INJURY REPORTED.
N/A
N/A
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 154711 | 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 | 60 YR | Male | UNKNOWN. |