FDA Adverse Event
Malfunction
Summary report: N
CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
MDR report key: 15174542
·
Received August 5, 2022
Report
- Report Number
- 2249723-2022-01949
- Event Type
- Malfunction
- Date Received
- August 5, 2022
- Date of Event
- July 20, 2022
- Report Date
- May 22, 2023
- 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
THE FSE THAT ENCOUNTERED THE ISSUE REPLACED THE 5000 HR PM KIT (0040-00-0147). THE FSE PERFORMED ALL FUNCTIONAL CHECKS. THE IABP WAS RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL USE.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD A SYSTEM FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1707884 | 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 | Unknown |