FDA Adverse Event
Malfunction
Summary report: N
CS300
MDR report key: 16635065
·
Received March 29, 2023
Report
- Report Number
- 2249723-2023-01669
- Event Type
- Malfunction
- Date Received
- March 29, 2023
- Date of Event
- March 17, 2023
- Report Date
- June 5, 2024
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567107882
- PMA / PMN Number
- K031636
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL CONTACT INFORMATION: (B)(6). A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT FOR THE REPORTED MALFUNCTION. THE FSE REPLACED THE FRONT END PCB. THE FSE PERFORMED A UNIT CHECKOUT. THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS. THE IABP WAS CLEARED FOR CLINICAL USE.
Additional Manufacturer Narrative · 0
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
Description of Event or Problem · 0
N/A.
Description of Event or Problem · 0
N/A.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAS AN ELECTRICAL FAILURE ALARM. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 910076 | CS300 | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. - MAHWAH | 0998-00-3023-53 | 10607567107882 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |