FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID, TYPE B PLUG
MDR report key: 17653493
·
Received August 30, 2023
Report
- Report Number
- 2249723-2023-03845
- Event Type
- Malfunction
- Date Received
- August 30, 2023
- Date of Event
- August 21, 2023
- Report Date
- April 24, 2024
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- 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
IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A FIBER OPTIC FAILURE. THE PATIENT INVOLVEMENT IS UNKNOWN. NO HARM REPORTED. A GETINGE FIELD SERVICE ENGINEER (FSE) UPON ARRIVAL, FOUND A DAMAGED FIBER OPTIC PORT.FIBER OPTIC PORT (D012-00-1562) AND JUMPER (D012-00-1808) REPLACED TO RESOLVE REPORTED ISSUE. CALIBRATIONS, FUNCTIONAL TESTING, AND SAFETY TESTING ALL PASSED PER FACTORY SPECIFICATIONS. UNIT HAS BEEN RETURNED TO CUSTOMER AND CLEARED FOR CLINICAL USE.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD AN FIBER OPTIC FAILURE. THERE WAS NO PATIENT INJURIES REPORTED.
Description of Event or Problem · 0
N/A
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1315119 | 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 | NA | Unknown |