FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID, TYPE B PLUG
MDR report key: 21334360
·
Received February 7, 2025
Report
- Report Number
- 2249723-2025-0000600
- Event Type
- Malfunction
- Date Received
- February 7, 2025
- Date of Event
- January 21, 2025
- Report Date
- May 15, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
Additional Manufacturer Narrative · 0
UPDATED FIELDS - B4, D9, G3, G6, H2, H3, H6 ( TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES INVESTIGATION CONCLUSION), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) REPLACED THE FIBER OPTIC CABLE ASSY (0012-00-1562) AND JUMPER CABLE (0012-00-1808) . UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS. RETURNED TO CUSTOMER AND CLEARED FOR USE.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE ALIGNMENT TABS OF FIBER-OPTIC SENSOR EXT CABLE ASSY FOR CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS BROKEN. THE ISSUE WAS FOUND WHILE CHANGING THE COIL CABLE, HENCE NO PATIENT INVOLVEMENT.
Description of Event or Problem · 0
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 125935 | 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 |