CARDIOSAVE HYBRID, TYPE B PLUG
Report
- Report Number
- 2249723-2025-0003008
- Event Type
- Malfunction
- Date Received
- July 14, 2025
- Date of Event
- June 29, 2025
- Report Date
- October 30, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION: DUE TO CHARACTERIZATION LIMIT E1 (EVENT SITE FULL NAME: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
UPDATED FIELDS - B4, G3, G6, H2, H3, H6 (HEALTH EFFECT ¿ CLINICAL CODE), H11. CORRECTED FIELD - D10.
UPDATED FIELDS - B4, G1, G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT, BUT WAS UNABLE TO REPRODUCE THE REPORTED MALFUNCTION. THE FIBER-OPTIC SYSTEM RECOGNIZED THE FSE'S CALIBRATION DEVICE AND WAS ABLE TO CONSISTENTLY RECEIVE AND TRANSMIT DATA WITHIN SPECIFICATIONS. THE UNIT WAS ALLOWED TO AUTOFILL AND CALIBRATE USING THE FIBER-OPTIC TESTER IN THE CLINICAL APPLICATION. THE UNIT WAS ABLE TO PROPERLY AUTOFILL AND DELIVER CONSISTENT THERAPY WITH THE TEST BALLOON. THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER MANUFACTURER SPECIFICATIONS.
IT WAS REPORTED THAT DURING USE, THE CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP) HAD AN ISSUE WITH THE FIBER OPTIC CABLE READINGS. NO PATIENT HARM OR INJURY IS REPORTED.
N/A
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1601709 | 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 | BALLOON CATHETER - UNKNOWN |