CARDIOSAVE HYBRID, TYPE B PLUG
Report
- Report Number
- 2249723-2024-00435
- Event Type
- Malfunction
- Date Received
- February 2, 2024
- Date of Event
- January 24, 2024
- Report Date
- November 7, 2024
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- 003
Narratives
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
CORRECTED DATA: B3. UPDATED DATA: B4, G3, G6, H2, H10, H11.
UPDATED FIELDS: (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS, COMPONENT CODE), H10 A GETINGE FIELD SERVICE ENGINEER (FSE) INVESTIGATED THE ISSUE AND FOUND THE AC LINE CORD REEL ASSEMBLY MISSING. FSE REPLACED (D012-00-1688-21 REEL, AC POWER CORD, DOMESTIC, TDK LAMBD) IN THE HOSPITAL CART 0997-00-1179 SN (B)(6). FSE COMPLETED PM PERFORMED WITH FULL CALIBRATION, FUNCTIONAL TESTING, AND ELECTRICAL SAFETY CHECKS TO FACTORY SPECIFICATIONS.
UDI RELATED DATA QUALITY UPDATES ONLY: PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID.
IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) , THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A DAMAGED AC LINE CORD REEL. THE GROUND PRONG WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
N/A.
N/A.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 348235 | CARDIOSAVE HYBRID, TYPE B PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0998-00-0800-53 | 10607567108391 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | N/A. |