CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V
Report
- Report Number
- 2249723-2024-01051
- Event Type
- Malfunction
- Date Received
- March 12, 2024
- Date of Event
- March 4, 2024
- Report Date
- October 23, 2024
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567107790
- PMA / PMN Number
- K031636
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
UPDATED DATA: B4, E1 (INITIAL REPORTER), E2, E3, G3, G6, H2, H10.
UDI RELATED DATA QUALITY UPDATES ONLY: PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID.
A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND RESOLVED THE ISSUE BY REPLACING MANIFOLD DRIVE AND HYDR CMPNT PUMP ASSY DC KNF. FSE THEN TESTED THE SAFETY AND FUNCTIONALITY AS PER FACTORY SPECIFICATIONS AND IABP WAS THEN RETURNED TO CUSTOMER FOR CLINICAL USE.
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION. E1 EVENT SITE NAME WAS SHORTENED DUE TO CHARACTER LIMITATIONS. THE COMPLETE NAME IS (B)(6). E1 EVENT SITE TELEPHONE WAS SHORTENED DUE TO CHARACTER LIMITATIONS. THE COMPLETE NUMBER IS (B)(6).
N/A.
N/A.
N/A.
IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) WAS FOUND TO INDICATE A SYSTEM FAILURE AND STOPPED OPERATING. THE BACKUP EQUIPMENT HAS BEEN REPLACED IMMEDIATELY. THERE WAS NO HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 725264 | CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0998-00-3013-45 | 10607567107790 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | UNKNOWN. |