FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID W/ E/F PLUG
MDR report key: 20605937
·
Received November 5, 2024
Report
- Report Number
- 2249723-2024-0004515
- Event Type
- Malfunction
- Date Received
- November 5, 2024
- Date of Event
- October 15, 2024
- Report Date
- February 7, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108414
- PMA / PMN Number
- K112372
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
Additional Manufacturer Narrative · 0
UPDATED FIELDS: B4,D8,D9,G3,G6,H2,H3,H4,H6(TYPE OF INVESTIGATION,INVESTIGATION FINDINGS,INVESTIGATION CONCLUSIONS,COMPONENT CODES),H11 A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE IABP UNIT AND WAS ABLE TO CONFIRM THE REPORTED ISSUE. FIBER OPTIC CABLE (0012-00-1808) WAS REPLACED, TESTS AND FUNCTIONAL TESTS WERE PERFORMED. EQUIPMENT SUITABLE FOR CLINICAL USE.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING DAILY INSPECTION PERFORMED BY CUSTOMER, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) FIBER OPTICS DOES NOT WORK THERE WAS NO PATIENT INVOLVEMENT.
Description of Event or Problem · 0
N/A
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1797237 | CARDIOSAVE HYBRID W/ E/F PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0998-00-0800-55 | 10607567108414 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |