FDA Adverse Event
Malfunction
Summary report: N
CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V
MDR report key: 12463406
·
Received September 13, 2021
Report
- Report Number
- 2249723-2021-02070
- Event Type
- Malfunction
- Date Received
- September 13, 2021
- Date of Event
- June 29, 2021
- Report Date
- February 21, 2024
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567107790
- PMA / PMN Number
- K031636
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
N/A.
Additional Manufacturer Narrative · 1
TESTING OF ACTUAL/SUSPECTED DEVICE (10/3233): A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE. THE FSE EVALUATED THE IABP UNIT AND FOUND THAT THE SAFETY DISK WAS FAULTY AND NEEDED TO BE REPLACED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS PROVIDED. THE FULL EVENT SITE NAME IS (B)(6) MEDICAL UNIV.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING USE ON A PATIENT THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) ALARMED "LOOP LEAK". NO PATIENT HARM, SERIOUS INJURY OR ADVERSE EVENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1358347 | CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. - MAHWAH | 0998-00-3013-45 | N/A | 10607567107790 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Female |