FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID, TYPE B PLUG
MDR report key: 16121729
·
Received January 9, 2023
Report
- Report Number
- 2249723-2023-00133
- Event Type
- Malfunction
- Date Received
- January 9, 2023
- Date of Event
- December 27, 2022
- Report Date
- January 20, 2024
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
Additional Manufacturer Narrative · 0
A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE IABP DURING ROUTINE CHECK AND WAS UNABLE TO REPRODUCE THE REPORTED ISSUE. NO PARTS WERE REMOVED AND UNIT WAS NOT NEEDING REPAIR THIS WAS A FALSE REPAIR WORK ORDER SUBMITTED. COMPLETED REPAIR WITH ALL FUNCTIONAL AND SAFETY TESTS PER MANUFACTURER SPECIFICATIONS.
Description of Event or Problem · 0
IT WAS REPORTED THAT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT IS NOT WORKING PROPERLY.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING ROUTINE CHECK, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT IS NOT WORKING PROPERLY.
Description of Event or Problem · 0
ADDITIONAL INFORMATION RECEIVED ON 5/4/23 STATING THAT EVENT OCCURRED ROUTINE CHECK, PATIENT INVOLVEMENT: NA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2305284 | CARDIOSAVE HYBRID, TYPE B PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. - MAHWAH | 0998-00-0800-53 | 10607567108391 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |