FDA Adverse Event
Malfunction
Summary report: N
CS100
MDR report key: 3261806
·
Received July 30, 2013
Report
- Report Number
- 2249723-2013-00061
- Event Type
- Malfunction
- Date Received
- July 30, 2013
- Date of Event
- May 30, 2013
- Report Date
- June 3, 2013
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- PMA / PMN Number
- K031636
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY REP REPLACED THE DRIVE MANIFOLD ASSEMBLY (PART NUMBER 0104-00-018). THE IABP WAS TESTED TO FACTORY SPECS. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT PRIOR TO USE ON A PT THE IABP SHUT DOWN AND GENERATED FAULT CODE #65 (SAFETY VENT FAILURE). THE IABP WAS REPLACED AND THERAPY WAS INITIATED. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 354374 | CS100 | INTRA-AORTIC BALLOON PUMP | DSP | DATASCOPE CORP. | CS100 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |