FDA Adverse Event
Malfunction
Summary report: N
CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V
MDR report key: 21570618
·
Received March 11, 2025
Report
- Report Number
- 2249723-2025-0001100
- Event Type
- Malfunction
- Date Received
- March 11, 2025
- Date of Event
- February 20, 2025
- Report Date
- April 29, 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
- 003
Narratives
Additional Manufacturer Narrative · 0
AFTER EVALUATING NEW INFORMATION THERE WAS NO MALFUNCTION TO THE IABP. THIS IS A DOWNGRADED EMDR. KINDLY CANCEL MFG REPORT NUMBER - 2249723-2025-0001100 FROM YOU DATA BASE.
Additional Manufacturer Narrative · 0
DUE TO CHARACTER LIMIT IN E1 FULL EVENT SITE NAME: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
Description of Event or Problem · 0
AFTER RECEIVING NEW INFORMATION IT WAS EVALUATED THAT THERE WAS NO MALFUNCTION TO THE IABP.
Description of Event or Problem · 0
IT WAS REPORTED DURING PM THAT A CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD 2500 HOURS MAINTENANCE RELATED MALFUNCTION. NO PATIENT WAS INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1308529 | 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 |