FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID, TYPE B PLUG
MDR report key: 20107348
·
Received August 30, 2024
Report
- Report Number
- 2249723-2024-03548
- Event Type
- Malfunction
- Date Received
- August 30, 2024
- Date of Event
- August 12, 2024
- Report Date
- August 29, 2024
- 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
Additional Manufacturer Narrative · 0
A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT. THE FSE REPLACED THE FIBER OPTIC SENSOR CABLE ASSEMBLY (D012-00-1562) AND THE FIBER OPTIC ASSEMBLY (D997-00-1169). THE FSE ALSO REINSTALLED B17 SOFTWARE. THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS AND WAS RETURNED TO THE CUSTOMER.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING A PRE SET UP, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A DAMAGED FIBER OPTIC PORT. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1794034 | 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 |