FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID, TYPE G PLUG
MDR report key: 19423105
·
Received May 30, 2024
Report
- Report Number
- 2249723-2024-02220
- Event Type
- Malfunction
- Date Received
- May 30, 2024
- Date of Event
- May 17, 2024
- Report Date
- June 3, 2024
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- 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
COMPLAINT RECORD BEING CANCELLED AS IT IS A DUPLICATE TO TW#(B)(4) ;MFG REPORT NUMBER 2249723-2024-02240. 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
IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) ECG SIGNAL SHOWED DISCONNECTION.
Description of Event or Problem · 0
COMPLAINT RECORD BEING CANCELLED AS IT IS A DUPLICATE TO TW#(B)(4) ;MFG REPORT NUMBER 2249723-2024-02240.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1275660 | CARDIOSAVE HYBRID, TYPE G PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. - MAHWAH | 0998-00-0800-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |