CARDIOSAVE HYBRID, TYPE B PLUG
Report
- Report Number
- 2249723-2025-0000293
- Event Type
- Malfunction
- Date Received
- January 27, 2025
- Date of Event
- January 3, 2025
- Report Date
- April 30, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 110607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
UPDATED FIELDS- B4, B5, B6, B7, D10, G3, G6, H2, H6 CODES (HEALTH EFFECT), H11.
UPDATED FIELDS- B4, B5, D8, G1(CONTACT PERSON-MFG SITE), G3, G6, H1, H2, H3, H6 CODES (INVESTIGATION TYPES, FINDINGS, CONCLUSION, PROBLEM CODE, COMPONENT CODE, HEALTH IMPACT), H11. GETINGE FSE VISTITED THE SITE AND EVALUATED THE PUMP AND FOUND TOUCH SCREEN NOT WORKING. CHANGED THE TOUCH SCREEN ASSEMBLY AND ISSUE WAS RESOLVED. FOR COMPLAINTS THAT WERE CONFIRMED TO HAVE NO TOUCH INPUT CAPA 802446 WAS INITIATED TO INVESTIGATE THE FAILURE OF NO TOUCH INPUT. THE CAPA IS CURRENTLY IN "ROOT CAUSE INVESTIGATION" STATE.
DUE CHARACTER LIMIT E1 EVENT SITE NAME: (B)(6). SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
IT WAS REPORTED THAT BEFORE USE CARDIOSAVE INTRA AORTIC BALLOON PUMP(IABP), TOUCH SCREEN WAS NOT WORKING. THERE WAS NO PATENT INVOLVED.
IT WAS REPORTED THAT DURING USE CARDIOSAVE INTRA AORTIC BALLOON PUMP(IABP), TOUCH SCREEN WAS NOT WORKING.
IT WAS REPORTED CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP), TOUCH SCREEN WAS NOT WORKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 466943 | CARDIOSAVE HYBRID, TYPE B PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0998-00-0800-53 | 110607567108391 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |