CARDIOSAVE HYBRID, TYPE B PLUG
Report
- Report Number
- 2249723-2023-04332
- Event Type
- Malfunction
- Date Received
- October 5, 2023
- Date of Event
- September 27, 2023
- Report Date
- September 16, 2024
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
- Health Professional
- N
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
UPDATED FIELD: B4, G3, G6, H2, H3, H6, H10. THE FOLLOWING INVESTIGATION WAS PERFORMED BY THE FAILURE ANALYSIS AND TESTING DEPT. (FAT) THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0997-00-1179 WITH A REPORTED UNIT FAILURE OF A BROKEN FRONT LEFT CASTER. THE FAT PERFORMED A VISUAL INSPECTION AND CONFIRMED THE PART TO BE BROKEN. PLEASE SEE ATTACHMENT. NO ROOT CAUSE DEFINED. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE.
A GETINGE FIELD SERVICE ENGINEER (FSE) REPLACED HOSPITAL CART. THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS.
IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAS A BROKEN CASTER.
N/A
N/A.
N//A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2261451 | 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. |