FDA Adverse Event
Malfunction
Summary report: N
CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
MDR report key: 16480866
·
Received March 3, 2023
Report
- Report Number
- 2249723-2023-01375
- Event Type
- Malfunction
- Date Received
- March 3, 2023
- Date of Event
- February 23, 2023
- Report Date
- March 11, 2024
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567107882
- PMA / PMN Number
- K063525
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL CONTACT INFORMATION: (B)(6). A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE IABP UNIT AND FOUND PRESSURE READINGS TO BE DISPLAYED BUT WHEN CABLE WAS MANIPULATED AT PRESSURE PORT CONNECTION READINGS WERE INTERMITTENT. REPLACED BP PRESSURE PORT ASSEMBLY(D012-00-0977).RAN AND PASSED ALL PERFORMANCE AND FUNCTION TESTS.
Additional Manufacturer Narrative · 0
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
Description of Event or Problem · 0
N/A.
Description of Event or Problem · 0
IT WAS REPORTED THAT , THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNITS PRESSURE PORT IS NOT WORKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1858077 | CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. - MAHWAH | 0998-00-3023-53 | 10607567107882 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | UNKNOWN. |