FDA Adverse Event
Malfunction
Summary report: N
CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V
MDR report key: 21717124
·
Received March 28, 2025
Report
- Report Number
- 2249723-2025-0001491
- Event Type
- Malfunction
- Date Received
- March 28, 2025
- Date of Event
- March 17, 2025
- Report Date
- June 11, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567107295
- PMA / PMN Number
- K031636
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TH
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DUE TO CHARACTER RESTRICTIONS IN BLOCK E1. EVENT SITE NAME: (B)(6) HOSPITAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
Additional Manufacturer Narrative · 0
UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE FAILURE MODE INVOLVED IN THE EVENT DID NOT LEAD TO AND DOES NOT HAVE POTENTIAL TO LEAD TO THE OUTCOMES OF A SERIOUS INCIDENT, MAKING IT NON-REPORTABLE TO THE FDA. AS A RESULT, NO FOLLOW UP EMDR IS NECESSARY. PLEASE CANCEL 2249723-2025-0001491 IN YOUR DATABASE.
Description of Event or Problem · 0
IT WAS REPORTED DURING PREVENTIVE MAINTENANCE THAT CS100 INTRA-AORTIC BALLOON PUMP (IABP) BROKEN WHEEL. THERE WAS NO PATIENT INVOLVEMENT AND NO INJURIES OR DEATHS.
Description of Event or Problem · 0
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1407276 | CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0998-00-3013-55 | 10607567107295 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | N/A. |