CARDIOSAVE HYBRID, TYPE B PLUG
Report
- Report Number
- 2249723-2024-01789
- Event Type
- Malfunction
- Date Received
- April 30, 2024
- Date of Event
- April 19, 2024
- Report Date
- February 3, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
**UDI RELATED DATA QUALITY UPDATES ONLY** PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID.
CORRECTED FIELDS: E1(INITIAL REPORTER). ADDITIONAL CONTACT INFORMATION: (B)(6). A GETINGE FIELD SERVICE ENGINEER (FSE) STATED THAT HE SPOKE WITH BEN CHAN, BWH BIOMED. HE IS FACTORY TRAINED AND WILL COMPLETE THE SERVICE CALL IN-HOUSE.CLINICAL STAFF MISTAKENLY CALLED GETINGE SERVICE INSTEAD OF CALLING IN HOUSE BIOMED.NO FURTHER INFORMATION IS AVAILABLE. THIS SO IS CLOSED. H3 OTHER TEXT : BIOMEDICAL ENGINEERING IS FACTORY TRAINED AND WILL BE HANDLING THIS REPAIR.
IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) PRINTER IS NOT PRINTING CLEAR. THERE WAS NO HARM TO PATIENT REPORTED.
N/A
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2068228 | 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 | UNKNOWN. |