FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID W/ E/F PLUG
MDR report key: 16090716
·
Received January 3, 2023
Report
- Report Number
- 2249723-2023-00025
- Event Type
- Malfunction
- Date Received
- January 3, 2023
- Date of Event
- December 15, 2022
- Report Date
- March 16, 2023
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567108414
- PMA / PMN Number
- K112372
- Removal / Correction Number
- 2249723-01/24/2023-004-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
Additional Manufacturer Narrative · 0
A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE THE ISSUE. THE FSE FOUND AN O-RING AND CONNECTOR BREAKAGE. SO, IN ORDER TO SOLVE THE ISSUE, THE FSE REPLACED THE O-RING (0354-00-0208) AND THE QUICK DISCONNECT FITTING (0103-00-0686). THE FSE THEN PERFORMED SENSOR CALIBRATION, FUNCTIONAL TESTS, AND THE UNIT WAS THEN CLEARED FOR CLINICAL USE.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING STARTUP, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT IS LEAKING HELIUM. THERE WAS NO PATIENT INVOLVEMENT.
Description of Event or Problem · 0
IT WAS REPORTED THAT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT IS LEAKING HELIUM. THERE WAS NO PATIENT INVOLVEMENT.
Description of Event or Problem · 0
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 132454 | CARDIOSAVE HYBRID W/ E/F PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. - MAHWAH | 0998-00-0800-55 | 10607567108414 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |