FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE
MDR report key: 19294875
·
Received May 11, 2024
Report
- Report Number
- 2249723-2024-01943
- Event Type
- Malfunction
- Date Received
- May 11, 2024
- Date of Event
- April 30, 2024
- Report Date
- May 10, 2024
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567108391
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
COMPLAINT RECORD BEING CANCELLED AS IT IS A DUPLICATE TO TW# (B)(4) ;MFG REPORT NUMBER 2249723-2024-01837. 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.
Description of Event or Problem · 0
COMPLAINT RECORD BEING CANCELLED AS IT IS A DUPLICATE TO TW# (B)(4) ;MFG REPORT NUMBER 2249723-2024-01837.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 970627 | CARDIOSAVE | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | 0998-00-0800-53 - CARDIOSAVE HYBRID DOMESTIC | N/A | 10607567108391 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |