FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID, TYPE G PLUG
MDR report key: 19446406
·
Received June 3, 2024
Report
- Report Number
- 2249723-2024-02265
- Event Type
- Malfunction
- Date Received
- June 3, 2024
- Date of Event
- May 20, 2024
- Report Date
- February 19, 2025
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567108438
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION: E1 (EVENT SITE STATE: SG, EVENT SITE POSTAL CODE: (B)(6)). A GETINGE FIELD SERVICE ENGINEER EVALUATED THE UNIT AND FOUND CABLE STUCK. IN ORDER TO FIX THE ISSUE FSE UNTANGLED CABLE REEL. TESTED CABLE FUNCTIONALITY. UNIT TESTED PASS IAW FACTORY SPECIFICATIONS. USER TO BE CAREFUL WHEN PULLING/RETRACTING CABLE. UNIT TESTED PASS AND HANDED TO USER.
Additional Manufacturer Narrative · 0
**UDI RELATED DATA QUALITY UPDATES ONLY** PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID (D1, D2, D3, D4, G4, H4, H5).
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
IT WAS REPORTED THAT BEFORE USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD A CABLE REEL STUCK. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1825457 | CARDIOSAVE HYBRID, TYPE G PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. - MAHWAH | 0998-00-0800-52 | 10607567108438 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |