FDA Adverse Event
Malfunction
Summary report: N
CS100
MDR report key: 17174638
·
Received June 21, 2023
Report
- Report Number
- 2249723-2023-02877
- Event Type
- Malfunction
- Date Received
- June 21, 2023
- Date of Event
- June 12, 2023
- Report Date
- February 27, 2024
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567107394
- PMA / PMN Number
- K031636
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- 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
A GETINGE FIELD SERVICE ENGINEER (FSE) CHECKED AND FOUND , IABP GIVEN ERROR ELECTRICAL FAILURE #06. IN ORDER TO RESOLVE THE ISSUE REPLACED PART: ASSEMBLY DSS DATASETTE CS100 D670-00-1185, ASSEMBLY IAB DATASETTE CS100 D670-00-1184, EXCH PCB,IABP MAIN BOARD D670-00-0788E.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING ROUTINE CHECK, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD AN ELECTRICAL TEST FAILURE #06. THERE WAS NO PATIENT INVOLVEMENT.
Description of Event or Problem · 0
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2014705 | CS100 | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. - MAHWAH | 0998-00-3013-53 | 10607567107394 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |