FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID, TYPE B PLUG
MDR report key: 21661221
·
Received March 21, 2025
Report
- Report Number
- 2249723-2025-0001345
- Event Type
- Malfunction
- Date Received
- March 21, 2025
- Date of Event
- March 5, 2025
- Report Date
- May 22, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
Additional Manufacturer Narrative · 0
THIS IS A DUPLICATE OF TW RECORD (B)(4). AFTER FURTHER INVESTIGATION, IT WAS IDENTIFIED THAT THIS COMPLAINT EVENT HAS BEEN REPORTED ALREADY UNDER MFG REPORT NUMBER 2249723-2025-0001338. PLEASE REFER TO MFG REPORT NUMBER 2249723-2025-0001338 FOR ALL INFORMATION FOR THIS COMPLAINT EVENT. PLEASE CANCEL MFG REPORT NUMBER 2249723-2025-0001345 IN YOUR DATABASE.
Description of Event or Problem · 0
IT WAS REPORTED DURING PREVENTIVE MAINTENANCE BY GETINGE FIELD SERVICE TECHNICIAN THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) FAILED PIM. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Description of Event or Problem · 0
CLOSED CANCELLED - DUPLICATE COMPLAINT OF (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1309273 | 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 |