FDA Adverse Event
Malfunction
Summary report: N
CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
MDR report key: 16822593
·
Received April 27, 2023
Report
- Report Number
- 2249723-2023-02097
- Event Type
- Malfunction
- Date Received
- April 27, 2023
- Date of Event
- April 10, 2023
- Report Date
- August 31, 2023
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567107882
- PMA / PMN Number
- K063525
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
Additional Manufacturer Narrative · 0
REVERT ALL SECTIONS TO BLANK : B. ADVERSE EVENT OR PRODUCT PROBLEM D. SUSPECT MEDICAL DEVICE E. INITIAL REPORTER G. ALL MANUFACTURERS H. DEVICE MANUFACTURERS ONLY. RECORD CANCELLED AS DUPLICATE OF TW# (B)(4) MFG REPORT NUMBER. 2249723-2023-02005.
Description of Event or Problem · 0
IT WAS REPORTED THAT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNITS MACHINE IS NOT SWITCHING ON.
Description of Event or Problem · 0
RECORD CANCELLED AS DUPLICATE OF TW# (B)(4) MFG REPORT NUMBER. 2249723-2023-02005.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1558421 | CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. - MAHWAH | 0998-00-3023-53 | 10607567107882 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | UNKNOWN. |