FDA Adverse Event
Malfunction
Summary report: N
CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
MDR report key: 16688860
·
Received April 6, 2023
Report
- Report Number
- 2249723-2023-01787
- Event Type
- Malfunction
- Date Received
- April 6, 2023
- Date of Event
- March 27, 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
- 003
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) AFTER DIAGNOSIS WE FOUND THAT 5000 HRS MAINTENANCE (D040-00-0147) KIT REQUIRED. ITS NEED TO BE REPLACED. THE FSE COMPLETED ALL SAFETY, FUNCTIONALITY, AND CALIBRATION CHECKS AND ALL TESTS PASSED TO FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE.
Description of Event or Problem · 0
IT WAS REPORTED THAT, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD AN AUTOFILL FAILURE ALARM.
Description of Event or Problem · 0
IT WAS REPORTED THAT, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD AN AUTOFILL FAILURE ALARM. THERE WAS NO PATIENT INVOLVEMENT.
Description of Event or Problem · 0
N/A
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1532177 | 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 |