FDA Adverse Event
Malfunction
Summary report: N
CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
MDR report key: 16340958
·
Received February 9, 2023
Report
- Report Number
- 2249723-2023-01032
- Event Type
- Malfunction
- Date Received
- February 9, 2023
- Date of Event
- January 27, 2023
- Report Date
- February 19, 2024
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567107394
- PMA / PMN Number
- K063525
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
Additional Manufacturer Narrative · 0
IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) WHEN POWERED ON, IT WAS SHOWING STATIC LINES. A GETINGE FIELD SERVICE ENGINEER FSE ARRIVED AT THE SITE CHECKED REPLACED THE LCD DISPLAY (D160-00-0113). AS A PRECAUTION FSE CHANGED MOUNTING CLAMP (D343-00-0073). RAN ALL THE TESTS IN ACCORDANCE TO THE MANUFACTURER'S SPECIFICATIONS. ALL TESTS ARE WITHIN RANGE. UNIT CLEARED FOR CLINICAL USE.
Description of Event or Problem · 0
IT WAS REPORTED THAT , THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNITS PCB POWER EXC. BOARD REPLACEMENT DUE.
Description of Event or Problem · 0
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1608080 | CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. - MAHWAH | 0998-00-3013-53 | 10607567107394 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | UNKNOWN. |